Manish A Patel1, Jeffrey C Gadsden2, Srdjan S Nedeljkovic3, Xiaodong Bao4, Jose L Zeballos5, Vincent Yu6, Sabry S Ayad7, Thomas F Bendtsen8. 1. Department of Orthopedic Surgery, Eastern Virginia Medical School, Franklin, Virginia. 2. Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina. 3. Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 4. Department of Anesthesia, Critical Care and Pain Management, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 5. Department of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 6. Biometrics, Pacira BioSciences, Inc., Parsippany, New Jersey. 7. Department of Anesthesiology, Fairview Hospital, Cleveland Clinic, Anesthesiology Institute, Outcomes Research, Cleveland, Ohio, USA. 8. Department of Anesthesia, Aarhus University Hospital, Aarhus, Denmark.
Abstract
OBJECTIVE: The utility of single-injection and continuous peripheral nerve blocks is limited by short duration of analgesia and catheter-related complications, respectively. This double-blind, multicenter trial evaluated the efficacy, safety, and pharmacokinetics of single-injection, ultrasound-guided brachial plexus block (BPB) with liposomal bupivacaine (LB) added to a standardized pain management protocol for shoulder surgery. METHODS:Adults undergoing total shoulder arthroplasty or rotator cuff repair were randomized to receive LB 133 mg, LB 266 mg (pharmacokinetic and safety analyses only), or placebo, added to a standardized analgesia protocol. The primary end point was area under the curve (AUC) of visual analog scale pain intensity scores through 48 hours postsurgery. Secondary end points were total opioid consumption, percentage of opioid-free patients, and time to first opioid rescue through 48 hours. Pharmacokinetic samples were collected through 120 hours and on days 7 and 10. Adverse events were documented. RESULTS:One hundred fifty-five patients received treatment (LB 133 mg, N = 69; LB 266 mg, N = 15; placebo, N = 71). BPB with LB 133 mg was associated with significantly improved AUC of pain scores (least squares mean [SE] = 136.4 [12.09] vs 254.1 [11.77], P < 0.0001), opioid consumption (least squares mean [SE] = 12.0 [2.27] vs 54.3 [10.05] mg, P < 0.0001), median time to opioid rescue (4.2 vs 0.6 h, P < 0.0001), and percentage of opioid-free patients (treatment difference = 0.166, 95% confidence interval = 0.032-0.200, P = 0.008) through 48 hours vs placebo. Adverse event incidence was comparable between groups. CONCLUSIONS: Single-injection BPB with LB 133 mg provided analgesia through 48 hours postsurgery with reduced opioid use compared with placebo after shoulder surgery.
RCT Entities:
OBJECTIVE: The utility of single-injection and continuous peripheral nerve blocks is limited by short duration of analgesia and catheter-related complications, respectively. This double-blind, multicenter trial evaluated the efficacy, safety, and pharmacokinetics of single-injection, ultrasound-guided brachial plexus block (BPB) with liposomal bupivacaine (LB) added to a standardized pain management protocol for shoulder surgery. METHODS: Adults undergoing total shoulder arthroplasty or rotator cuff repair were randomized to receive LB 133 mg, LB 266 mg (pharmacokinetic and safety analyses only), or placebo, added to a standardized analgesia protocol. The primary end point was area under the curve (AUC) of visual analog scale pain intensity scores through 48 hours postsurgery. Secondary end points were total opioid consumption, percentage of opioid-free patients, and time to first opioid rescue through 48 hours. Pharmacokinetic samples were collected through 120 hours and on days 7 and 10. Adverse events were documented. RESULTS: One hundred fifty-five patients received treatment (LB 133 mg, N = 69; LB 266 mg, N = 15; placebo, N = 71). BPB with LB 133 mg was associated with significantly improved AUC of pain scores (least squares mean [SE] = 136.4 [12.09] vs 254.1 [11.77], P < 0.0001), opioid consumption (least squares mean [SE] = 12.0 [2.27] vs 54.3 [10.05] mg, P < 0.0001), median time to opioid rescue (4.2 vs 0.6 h, P < 0.0001), and percentage of opioid-free patients (treatment difference = 0.166, 95% confidence interval = 0.032-0.200, P = 0.008) through 48 hours vs placebo. Adverse event incidence was comparable between groups. CONCLUSIONS: Single-injection BPB with LB 133 mg provided analgesia through 48 hours postsurgery with reduced opioid use compared with placebo after shoulder surgery.
Authors: Tristan B Weir; Nana Simpson; Ali Aneizi; Michael J Foster; Julio J Jauregui; Mohit N Gilotra; R Frank Henn Iii; S Ashfaq Hasan Journal: J Orthop Date: 2020-05-11
Authors: Tristan B Weir; Tina Zhang; Julio J Jauregui; Ali Aneizi; Patrick M J Sajak; Matheus B Schneider; Mohit N Gilotra; Joshua M Abzug; R Frank Henn; Ngozi M Akabudike Journal: J Am Acad Orthop Surg Glob Res Rev Date: 2021-06-02