EVALUATION OF EXPAREL

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1 EVALUATION OF EXPAREL USE VIA INFILTRATION INTO THE TRANSVERSUS ABDOMINIS PLANE FOR PROLONGED POSTOPERATIVE ANALGESIA IN SUBJECTS UNDERGOING OPEN ABDOMINAL HERNIA REPAIR Dennis E. Feierman, Mark Kronenfeld, Piyush M. Gupta, Natalie Younger, Eduard Logvinskiy Anesthesiology, Maimonides Medical Center, Brooklyn, NY, USA ABSTRACT The TAP block has been successfully used for postoperative pain relief for surgical procedures involving incisions of the mid and lower abdominal wall. From our historical experience using bupivacaine for TAP blocks, the pain relief lasts hours. A new extended-release liposomal bupivacaine, Exparel, was FDA approved in. This drug was shown to provide pain relief for up to 7 hours when injected into a surgical wound. The objective of this study was to assess the safety and efficacy of Exparel when it is infiltrated bilaterally into the TAP to provide prolonged postoperative analgesia in patients undergoing umbilical hernia repair. After IRB approval, patients consented to participate in the study. The study included patients undergoing open umbilical hernia repair under general anesthesia, with an incision length of between and cm. All patients met our inclusion and exclusion criteria. Using ultrasound guidance, a bilateral TAP block was performed at the end of surgery, prior to the end of general anesthesia. Twenty ml of Exparel was diluted with normal saline to a total of ml. After identifying the TAP using a ml hydro-dissection of normal saline, ml of the diluted Exparel was injected into the TAP on each side, for a total of ml for the bilateral TAP block. Pain scores were recorded at,,,,,, 7, 9 and hrs after the TAP block using a using an -point numeric rating scale (, with being severe pain). In addition, overall subject satisfaction with postsurgical pain control was assessed using a -point Likert scale (with being most satisfied) at the time of hospital discharge and at the postsurgical follow-up. Of patients treated, one block failed at the outset. This patient had significant pain and was admitted overnight for pain control. This patient reported a pain score of for the first hours postoperatively and at hours. None of the patients reported any serious The remaining patients reported significant pain control (values are the mean ± SEM). Pain control lasted at least 7 hours on the patients with successful TAP blocks with diluted Exparel. self-reported to be extremely satisfied with their pain control, with a Likert score of.±. at discharge and a Likert score of.7±. at their follow-up surgical visit. Exparel can be successfully used in a bilateral TAP block for extended postoperative pain control after open umbilical hernia repairs. Additionally, patients self-reported to be extremely satisfied with their pain control at discharge and at their follow-up surgical visit. INTRODUCTION A variety of surgical procedures requiring incisions to the mid and lower abdominal wall involve use of a local anesthetic administered in the transversus abdominis plane (TAP) for postoperative pain relief., A recent meta-analysis showed that patients undergoing abdominal surgery with a TAP infiltration experience less pain, use fewer opioids, and have lower incidences of opioid-related side effects, such as nausea and vomiting, at hours after surgery than patients without a TAP infiltration. In patients undergoing inguinal hernia repair, TAP infiltration has been shown to provide greater postsurgical analgesia and reduce opioid use compared with ilioinguinal/iliohypogastric nerve block and conventional local anesthesia via wound infiltration. Typically, in our surgical practice, we have observed TAP infiltration with bupivacaine HCl to provide persistent analgesia for about to hours after abdominal surgery. A prolonged-release formulation of bupivacaine (bupivacaine liposome injectable suspension; EXPAREL, Pacira Pharmaceuticals, Parsippany, NJ) was approved by the US Food and Drug Administration (FDA) in for administration into the surgical site to produce postsurgical analgesia. In randomized, controlled trials, a single intraoperative administration of liposome bupivacaine into the surgical wound provided analgesia for up to 7 hours and was well tolerated at doses mg. 7 The objective of the current study was to assess the safety and efficacy of liposome bupivacaine infiltrated into the TAP in patients undergoing ventral abdominal wall hernia repair. METHODS The study included adult men and women (aged 7 years) who had American Society of Anesthesiologists (ASA) Physical Classification Status to and underwent open ventral abdominal wall hernia repair under general anesthesia with an incision length between and cm. Key exclusion criteria included history of hypersensitivity to amide-type local anesthetics, chronic use of analgesics, and pregnancy. The TAP was identified using a -ml hydro-dissection of normal saline and then infiltrated bilaterally in open-label fashion with a total of mg of liposome bupivacaine ( ml) diluted with preservative-free.9% normal saline to a volume of ml ( ml infiltrated on each side) immediately after surgery, using ultrasound guidance. Study drug was administered via a standardized protocol, using the same syringe size, needle gauge, needle placement, and infiltration rate in all patients. All patients had access to rescue analgesics after surgery. Patient-reported pain intensity was assessed prior to the infiltration into the TAP (Time ), at,,,,,, 7, 9, and hours after TAP infiltration, and at days after surgery. Data were summarized using descriptive statistics. Patient-reported pain intensity, based on an -point numeric rating scale (NRS; =no pain, =worst possible pain), assessed before surgery and at scheduled intervals up to days after surgery Time to first administration of supplemental analgesia after TAP infiltration Incidence of opioid-related adverse events (AEs), defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, urinary retention, sedation, confusion, Overall patient satisfaction with postsurgical pain control reported using a -point Likert scale (=not at all satisfied, =extremely satisfied) at hospital discharge and days after surgery AEs and serious AEs monitored through postsurgical Day A total of patients were enrolled and completed the study and were included in the analysis; most were white (77%) and classified as ASA Physical Status or (Table ). Table. Patient Demographics and Baseline Characteristics (N=) Variable Value Age, mean (SD), y () White (77) Black () Asian () ASA Physical Classification, n (%) () 9 (9) () Proportion of patients taking opioids regularly during previous mo ASA=American Society of Anesthesiologists. Mean patient-reported NRS was. prior to TAP infiltration and remained below through hours after surgery (Figure ). A total of patients reported NRS scores at one or more time points through hours after surgery; thereafter, all observed pain scores were <. One patient had a failed TAP infiltration and experienced significant postsurgical pain (NRS scores of at hours and at hours after surgery) and was admitted overnight for pain control. Figure. Patient-Reported Scores on Numeric Rating Scale at to Hours Post-surgery 7 9 By hours post-surgery, the mean NRS score (.9) was similar to presurgical levels and remained low (.) at the Day assessments. The median time to first use of supplemental analgesia after surgery was hours (range < to 7 h). Time to first administration of supplemental analgesia for the patients who required postsurgical analgesics is summarized in Figure. Figure. Time to First Postsurgical Use of Supplemental Analgesia < to < to < to < to < to <7 7 Most patients reported they were satisfied or extremely satisfied with postsurgical pain control at discharge and at Day after surgery (Figure ). Figure. Patient Satisfaction With Postsurgical Pain Control 9 7 Discharge Extremely Satisfied Satisfied Neutral Day Mean patient-reported satisfaction scores were./ at discharge and./ at the Day follow-up visit. There were no AEs reported during the study; however, the infiltration into the TAP failed in one patient. CONCLUSIONS TAP infiltration with liposome bupivacaine provided prolonged postsurgical analgesia through 7 hours after surgery in these adults who underwent open ventral abdominal hernia repair, with no reported Most patients reported being satisfied or extremely satisfied with postsurgical pain control. TAP infiltration with liposome bupivacaine merits further study for postsurgical pain control in patients undergoing open abdominal hernia repair. REFERENCES. Niraj G, Searle A, Mathews M, et al. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 9;:-.. Johns N, O Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. ;:e-e.. Aveline C, Le HH, Le RA, et al. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. ;:-.. Milone M, Di Minno MN, Musella M, et al. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. Nov [Epub ahead of print].. Exparel [package insert]. San Diego, CA: Pacira Pharmaceuticals, Inc.;.. Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. ;: Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. Feb [Epub ahead of print].

2 EVALUATION OF EXPAREL USE VIA INFILTRATION INTO THE TRANSVERSUS ABDOMINIS PLANE FOR PROLONGED POSTOPERATIVE ANALGESIA IN SUBJECTS UNDERGOING OPEN ABDOMINAL HERNIA REPAIR Dennis E. Feierman, Mark Kronenfeld, Piyush M. Gupta, Natalie Younger, Eduard Logvinskiy Anesthesiology, Maimonides Medical Center, Brooklyn, NY, USA ABSTRACT The TAP block has been successfully used for postoperative pain relief for surgical procedures involving incisions of the mid and lower abdominal wall. From our historical experience using bupivacaine for TAP blocks, the pain relief lasts hours. A new extended-release liposomal bupivacaine, Exparel, was FDA approved in. This drug was shown to provide pain relief for up to 7 hours when injected into a surgical wound. The objective of this study was to assess the safety and efficacy of Exparel when it is infiltrated bilaterally into the TAP to provide prolonged postoperative analgesia in patients undergoing umbilical hernia repair. After IRB approval, patients consented to participate in the study. The study included patients undergoing open umbilical hernia repair under general anesthesia, with an incision length of between and cm. All patients met our inclusion and exclusion criteria. Using ultrasound guidance, a bilateral TAP block was performed at the end of surgery, prior to the end of general anesthesia. Twenty ml of Exparel was diluted with normal saline to a total of ml. After identifying the TAP using a ml hydro-dissection of normal saline, ml of the diluted Exparel was injected into the TAP on each side, for a total of ml for the bilateral TAP block. Pain scores were recorded at,,,,,, 7, 9 and hrs after the TAP block using a using an -point numeric rating scale (, with being severe pain). In addition, overall subject satisfaction with postsurgical pain control was assessed using a -point Likert scale (with being most satisfied) at the time of hospital discharge and at the postsurgical follow-up. Of patients treated, one block failed at the outset. This patient had significant pain and was admitted overnight for pain control. This patient reported a pain score of for the first hours postoperatively and at hours. None of the patients reported any serious The remaining patients reported significant pain control (values are the mean ± SEM). Pain control lasted at least 7 hours on the patients with successful TAP blocks with diluted Exparel. self-reported to be extremely satisfied with their pain control, with a Likert score of.±. at discharge and a Likert score of.7±. at their follow-up surgical visit. Exparel can be successfully used in a bilateral TAP block for extended postoperative pain control after open umbilical hernia repairs. Additionally, patients self-reported to be extremely satisfied with their pain control at discharge and at their follow-up surgical visit. INTRODUCTION A variety of surgical procedures requiring incisions to the mid and lower abdominal wall involve use of a local anesthetic administered in the transversus abdominis plane (TAP) for postoperative pain relief., A recent meta-analysis showed that patients undergoing abdominal surgery with a TAP infiltration experience less pain, use fewer opioids, and have lower incidences of opioid-related side effects, such as nausea and vomiting, at hours after surgery than patients without a TAP infiltration. In patients undergoing inguinal hernia repair, TAP infiltration has been shown to provide greater postsurgical analgesia and reduce opioid use compared with ilioinguinal/iliohypogastric nerve block and conventional local anesthesia via wound infiltration. Typically, in our surgical practice, we have observed TAP infiltration with bupivacaine HCl to provide persistent analgesia for about to hours after abdominal surgery. A prolonged-release formulation of bupivacaine (bupivacaine liposome injectable suspension; EXPAREL, Pacira Pharmaceuticals, Parsippany, NJ) was approved by the US Food and Drug Administration (FDA) in for administration into the surgical site to produce postsurgical analgesia. In randomized, controlled trials, a single intraoperative administration of liposome bupivacaine into the surgical wound provided analgesia for up to 7 hours and was well tolerated at doses mg. 7 The objective of the current study was to assess the safety and efficacy of liposome bupivacaine infiltrated into the TAP in patients undergoing ventral abdominal wall hernia repair. METHODS The study included adult men and women (aged 7 years) who had American Society of Anesthesiologists (ASA) Physical Classification Status to and underwent open ventral abdominal wall hernia repair under general anesthesia with an incision length between and cm. Key exclusion criteria included history of hypersensitivity to amide-type local anesthetics, chronic use of analgesics, and pregnancy. The TAP was identified using a -ml hydro-dissection of normal saline and then infiltrated bilaterally in open-label fashion with a total of mg of liposome bupivacaine ( ml) diluted with preservative-free.9% normal saline to a volume of ml ( ml infiltrated on each side) immediately after surgery, using ultrasound guidance. Study drug was administered via a standardized protocol, using the same syringe size, needle gauge, needle placement, and infiltration rate in all patients. All patients had access to rescue analgesics after surgery. Patient-reported pain intensity was assessed prior to the infiltration into the TAP (Time ), at,,,,,, 7, 9, and hours after TAP infiltration, and at days after surgery. Data were summarized using descriptive statistics. Patient-reported pain intensity, based on an -point numeric rating scale (NRS; =no pain, =worst possible pain), assessed before surgery and at scheduled intervals up to days after surgery Time to first administration of supplemental analgesia after TAP infiltration Incidence of opioid-related adverse events (AEs), defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, urinary retention, sedation, confusion, Overall patient satisfaction with postsurgical pain control reported using a -point Likert scale (=not at all satisfied, =extremely satisfied) at hospital discharge and days after surgery AEs and serious AEs monitored through postsurgical Day A total of patients were enrolled and completed the study and were included in the analysis; most were white (77%) and classified as ASA Physical Status or (Table ). Mean patient-reported NRS was. prior to TAP infiltration and remained below through hours after surgery (Figure ). A total of patients reported NRS scores at one or more time points through hours after surgery; thereafter, all observed pain scores were <. One patient had a failed TAP infiltration and experienced significant postsurgical pain (NRS scores of at hours and at hours after surgery) and was admitted overnight for pain control. 7 9 By hours post-surgery, the mean NRS score (.9) was similar to presurgical levels and remained low (.) at the Day assessments. The median time to first use of supplemental analgesia after surgery was hours (range < to 7 h). Time to first administration of supplemental analgesia for the patients who required postsurgical analgesics is summarized in Figure. < to < to < to < to < to <7 7 Most patients reported they were satisfied or extremely satisfied with postsurgical pain control at discharge and at Day after surgery (Figure ). 9 7 Discharge Extremely Satisfied Satisfied Neutral Day Table. Patient Demographics and Baseline Characteristics (N=) Variable Value Age, mean (SD), y () White (77) Black () Asian () ASA Physical Classification, n (%) () 9 (9) () Proportion of patients taking opioids regularly during previous mo ASA=American Society of Anesthesiologists. Figure. Patient-Reported Scores on Numeric Rating Scale at to Hours Post-surgery Figure. Time to First Postsurgical Use of Supplemental Analgesia Figure. Patient Satisfaction With Postsurgical Pain Control Mean patient-reported satisfaction scores were./ at discharge and./ at the Day follow-up visit. There were no AEs reported during the study; however, the infiltration into the TAP failed in one patient. CONCLUSIONS TAP infiltration with liposome bupivacaine provided prolonged postsurgical analgesia through 7 hours after surgery in these adults who underwent open ventral abdominal hernia repair, with no reported Most patients reported being satisfied or extremely satisfied with postsurgical pain control. TAP infiltration with liposome bupivacaine merits further study for postsurgical pain control in patients undergoing open abdominal hernia repair. REFERENCES. Niraj G, Searle A, Mathews M, et al. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 9;:-.. Johns N, O Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. ;:e-e.. Aveline C, Le HH, Le RA, et al. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. ;:-.. Milone M, Di Minno MN, Musella M, et al. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. Nov [Epub ahead of print].. Exparel [package insert]. San Diego, CA: Pacira Pharmaceuticals, Inc.;.. Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. ;: Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. Feb [Epub ahead of print].

3 ABSTRACT The TAP block has been successfully used for postoperative pain relief for surgical procedures involving incisions of the mid and lower abdominal wall. From our historical experience using bupivacaine for TAP blocks, the pain relief lasts hours. A new extended-release liposomal bupivacaine, Exparel, was FDA approved in. This drug was shown to provide pain relief for up to 7 hours when injected into a surgical wound. The objective of this study was to assess the safety and efficacy of Exparel when it is infiltrated bilaterally into the TAP to provide prolonged postoperative analgesia in patients undergoing umbilical hernia repair. After IRB approval, patients consented to participate in the study. The study included patients undergoing open umbilical hernia repair under general anesthesia, with an incision length of between and cm. All patients met our inclusion and exclusion criteria. Using ultrasound guidance, a bilateral TAP block was performed at the end of surgery, prior to the end of general anesthesia. Twenty ml of Exparel was diluted with normal saline to a total of ml. After identifying the TAP using a ml hydro-dissection of normal saline, ml of the diluted Exparel was injected into the TAP on each side, for a total of ml for the bilateral TAP block. Pain scores were recorded at,,,,,, 7, 9 and hrs after the TAP block using a using an -point numeric rating scale (, with being severe pain). In addition, overall subject satisfaction with postsurgical pain control was assessed using a -point Likert scale (with being most satisfied) at the time of hospital discharge and at the postsurgical follow-up. Of patients treated, one block failed at the outset. This patient had significant pain and was admitted overnight for pain control. This patient reported a pain score of for the first hours postoperatively and at hours. None of the patients reported any serious The remaining patients reported significant pain control (values are the mean ± SEM). Pain control lasted at least 7 hours on the patients with successful TAP blocks with diluted Exparel. self-reported to be extremely satisfied with their pain control, with a Likert score of.±. at discharge and a Likert score of.7±. at their follow-up surgical visit. Exparel can be successfully used in a bilateral TAP block for extended postoperative pain control after open umbilical hernia repairs. Additionally, patients self-reported to be extremely satisfied with their pain control at discharge and at their follow-up surgical visit. INTRODUCTION A variety of surgical procedures requiring incisions to the mid and lower abdominal wall involve use of a local anesthetic administered in the transversus abdominis plane (TAP) for postoperative pain relief., A recent meta-analysis showed that patients undergoing abdominal surgery with a TAP infiltration experience less pain, use fewer opioids, and have lower incidences of opioid-related side effects, such as nausea and vomiting, at hours after surgery than patients without a TAP infiltration. In patients undergoing inguinal hernia repair, TAP infiltration has been shown to provide greater postsurgical analgesia and reduce opioid use compared with ilioinguinal/iliohypogastric nerve block and conventional local anesthesia via wound infiltration. Typically, in our surgical practice, we have observed TAP infiltration with bupivacaine HCl to provide persistent analgesia for about to hours after abdominal surgery. A prolonged-release formulation of bupivacaine (bupivacaine liposome injectable suspension; EXPAREL, Pacira Pharmaceuticals, Parsippany, NJ) was approved by the US Food and Drug Administration (FDA) in for administration into the surgical site to produce postsurgical analgesia. In randomized, controlled trials, a single intraoperative administration of liposome bupivacaine into the surgical wound provided analgesia for up to 7 hours and was well tolerated at doses mg. 7 The objective of the current study was to assess the safety and efficacy of liposome bupivacaine infiltrated into the TAP in patients undergoing ventral abdominal wall hernia repair. METHOD The study include Anesthesiologists hernia repair unde Key exclusion crit analgesics, and pr The TAP was iden open-label fashion.9% normal salin ultrasound guidan Study drug was a placement, and in All patients had ac Patient-reported p, 7, 9, and Data were summa Patient-reported p possible pain), as Time to first admi Incidence of opioi hypoventilation, h Overall patient sat satisfied, =extrem AEs and serious A A total of patie white (77%) and c Table. Patient De Variable Age, mean (SD), y White Black Asian ASA Physical Classification Proportion of patients takin ASA=American Society of Ane

4 Dennis E. Feierman, Mark Kronenfeld, Piyush M. Gup Anesthesiology, Maimonides Medical C ical procedures involving using bupivacaine for TAP pivacaine, Exparel, was FDA rs when injected into a surgical arel when it is infiltrated s undergoing umbilical included patients undergoing of between and cm. e, a bilateral TAP block was ml of Exparel was diluted with -dissection of normal saline, l of ml for the bilateral TAP fter the TAP block using a using, overall subject satisfaction with ng most satisfied) at the time of t pain and was admitted hours postoperatively and e remaining patients reported st 7 hours on the patients xtremely satisfied with their pain. at their follow-up surgical visit. erative pain control after open tisfied with their pain control at bdominal wall involve use ) for postoperative pain relief., y with a TAP infiltration id-related side effects, such as infiltration. wn to provide greater postsurgical nerve block and conventional upivacaine HCl to provide ctable suspension; EXPAREL, d Drug Administration (FDA) in esia. posome bupivacaine into the ted at doses mg. 7 liposome bupivacaine infiltrated METHODS The study included adult men and women (aged 7 years) who had American Society of Anesthesiologists (ASA) Physical Classification Status to and underwent open ventral abdominal wall hernia repair under general anesthesia with an incision length between and cm. Key exclusion criteria included history of hypersensitivity to amide-type local anesthetics, chronic use of analgesics, and pregnancy. The TAP was identified using a -ml hydro-dissection of normal saline and then infiltrated bilaterally in open-label fashion with a total of mg of liposome bupivacaine ( ml) diluted with preservative-free.9% normal saline to a volume of ml ( ml infiltrated on each side) immediately after surgery, using ultrasound guidance. Study drug was administered via a standardized protocol, using the same syringe size, needle gauge, needle placement, and infiltration rate in all patients. All patients had access to rescue analgesics after surgery. Patient-reported pain intensity was assessed prior to the infiltration into the TAP (Time ), at,,,,,, 7, 9, and hours after TAP infiltration, and at days after surgery. Data were summarized using descriptive statistics. Patient-reported pain intensity, based on an -point numeric rating scale (NRS; =no pain, =worst possible pain), assessed before surgery and at scheduled intervals up to days after surgery Time to first administration of supplemental analgesia after TAP infiltration Incidence of opioid-related adverse events (AEs), defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, urinary retention, sedation, confusion, Overall patient satisfaction with postsurgical pain control reported using a -point Likert scale (=not at all satisfied, =extremely satisfied) at hospital discharge and days after surgery AEs and serious AEs monitored through postsurgical Day A total of patients were enrolled and completed the study and were included in the analysis; most were white (77%) and classified as ASA Physical Status or (Table ). Table. Patient Demographics and Baseline Characteristics (N=) Variable Value Age, mean (SD), y () White (77) Black () Asian () ASA Physical Classification, n (%) () 9 (9) () Proportion of patients taking opioids regularly during previous mo ASA=American Society of Anesthesiologists. Mean patient-repor surgery (Figure ). A total of patients thereafter, all obser One patient had at hours an Figure. Patient-Rep By hours post- (.) at the Day The median time to Time to first adm analgesics is sum Figure. Time to Fir <

5 Mark Kronenfeld, Piyush M. Gupta, Natalie Younger, Eduard Logvinskiy Anesthesiology, Maimonides Medical Center, Brooklyn, NY, USA erican Society of nt open ventral abdominal wall nd cm. al anesthetics, chronic use of then infiltrated bilaterally in ) diluted with preservative-free immediately after surgery, using syringe size, needle gauge, needle e TAP (Time ), at,,,,, ry. (NRS; =no pain, =worst days after surgery respiratory depression, ry retention, sedation, confusion, -point Likert scale (=not at all rgery Mean patient-reported NRS was. prior to TAP infiltration and remained below through hours after surgery (Figure ). A total of patients reported NRS scores at one or more time points through hours after surgery; thereafter, all observed pain scores were <. One patient had a failed TAP infiltration and experienced significant postsurgical pain (NRS scores of at hours and at hours after surgery) and was admitted overnight for pain control. Figure. Patient-Reported Scores on Numeric Rating Scale at to Hours Post-surgery 7 9 By hours post-surgery, the mean NRS score (.9) was similar to presurgical levels and remained low (.) at the Day assessments. The median time to first use of supplemental analgesia after surgery was hours (range < to 7 h). Time to first administration of supplemental analgesia for the patients who required postsurgical analgesics is summarized in Figure. Most patients repor discharge and at Da Figure. Patient Sat 9 7 Mean patient-repor There were no AEs CONCLUSI TAP infiltration w after surgery in th Most patients rep TAP infiltration w undergoing open uded in the analysis; most were Value () (77) () () () 9 (9) () Figure. Time to First Postsurgical Use of Supplemental Analgesia < to < to < to < to < to <7 7 REFERENC. Niraj G, Searle A, Mathe undergoing open appen. Johns N, O Neill S, Ven block in abdominal surg. Aveline C, Le HH, Le RA ilioinguinal/iliohypogast. Milone M, Di Minno MN ultrasound-guided trans. Exparel [package inser. Bergese SD, Ramamoo formulation of bupivaca 7. Viscusi ER, Sinatra R, O J Pain. Feb [Ep

6 Logvinskiy below through hours after Most patients reported they were satisfied or extremely satisfied with postsurgical pain control at discharge and at Day after surgery (Figure ). rough hours after surgery; Figure. Patient Satisfaction With Postsurgical Pain Control tsurgical pain (NRS scores of ight for pain control. 9 Extremely Satisfied Satisfied Neutral Hours Post-surgery 7 Discharge Day Mean patient-reported satisfaction scores were./ at discharge and./ at the Day follow-up visit. There were no AEs reported during the study; however, the infiltration into the TAP failed in one patient. 7 9 CONCLUSIONS urgical levels and remained low hours (range < to 7 h). ts who required postsurgical TAP infiltration with liposome bupivacaine provided prolonged postsurgical analgesia through 7 hours after surgery in these adults who underwent open ventral abdominal hernia repair, with no reported Most patients reported being satisfied or extremely satisfied with postsurgical pain control. TAP infiltration with liposome bupivacaine merits further study for postsurgical pain control in patients undergoing open abdominal hernia repair. REFERENCES to <7 7. Niraj G, Searle A, Mathews M, et al. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 9;:-.. Johns N, O Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. ;:e-e.. Aveline C, Le HH, Le RA, et al. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. ;:-.. Milone M, Di Minno MN, Musella M, et al. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. Nov [Epub ahead of print].. Exparel [package insert]. San Diego, CA: Pacira Pharmaceuticals, Inc.;.. Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. ;: Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. Feb [Epub ahead of print].

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