Admir Hadzic1, Harold S Minkowitz, Timothy I Melson, Richard Berkowitz, Anna Uskova, Forrest Ringold, Janice Lookabaugh, Brian M Ilfeld. 1. From the Departments of Anesthesiology, St. Luke's and Roosevelt Hospitals, New York, New York, and Ziekenhouse Oost Limburgh, Genk, Belgium, and the New York School of Regional Anesthesia (NYSORA), New York, New York (A.H.); Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas (H.S.M.); Department of Anesthesiology, Sheffield Anesthesia, Helen Keller Memorial Hospital, Sheffield, Alabama (T.I.M.); Department of Joint Replacement Surgery, University Hospital, Tamarac, Florida (R.B.); Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (A.U.); Veritas Research, LLC, Mobile, Alabama (F.R.); Pacira Pharmaceuticals, Inc., Parsippany, New Jersey (J.L.); and Department of Anesthesiology, University of California, San Diego, San Diego, California (B.M.I.).
Abstract
BACKGROUND: The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty. METHODS: Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication. RESULTS: In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively). CONCLUSION:FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.
RCT Entities:
BACKGROUND: The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty. METHODS: Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication. RESULTS: In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacainepatients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively). CONCLUSION:FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.
Authors: Catalina I Dumitrascu; Nafisseh S Warner; Thomas M Stewart; Adam W Amundson; Danette L Bruns; Andrew C Hanson; Phillip J Schulte; Mark M Smith; Michael J Brown; Adam D Niesen; Carlos B Mantilla; Matthew A Warner Journal: Pain Pract Date: 2020-11-04 Impact factor: 3.183