Single-injection brachial plexus block (BPB) with liposomal bupivacaine may provide analgesia for 48 hours following shoulder surgery and reduce opioid use, according to a study published in Pain Medicine.
This double-blind multicenter trial was conducted to examine the efficacy, safety, and pharmacokinetics of single-injection, ultrasound-guided BPB with liposomal bupivacaine in combination with a standardized pain management protocol in patients undergoing total shoulder arthroplasty or rotator cuff repair. Exclusion criteria included concurrent surgery or a condition that may have required postoperative analgesics; contraindication to bupivacaine or oxycodone; hypersensitivity or idiosyncratic reaction to amide-type local anesthetics; smoking history ≥25 pack-years; substance abuse within the past 1 year; body mass index >44 kg/m²; renal impairment, chronic respiratory disease, rheumatoid arthritis, or coagulopathy; history of malignancy within 2 years; current renal or hepatic impairment; uncontrolled psychiatric or neurologic disorder; and chronic neuromuscular deficit affecting the surgical limb.
Study participants were randomly assigned to receive liposomal bupivacaine 133 mg (n=69) or 266 mg (n=15; for pharmacokinetic and safety analyses only), or placebo (n=71), in addition to a standardized analgesia protocol. Pain intensity scores were assessed using a 10-cm visual analog scale on day 0, upon post-anesthesia care unit arrival, every 15 minutes thereafter, at post-anesthesia care unit discharge, at 6, 12, 24, 36, 48, 60, and 72 hours, and immediately before each rescue medication dose through 72 hours. Overall Benefit of Analgesia Score and patient satisfaction with overall analgesia were assessed with a 5-point Likert scale at 24 and 72 hours and on postsurgical day 10. Adverse events were documented through postsurgical day 29. Pharmacokinetic samples were collected up until 120 hours, and on days 7 and 10.
Use of BPB with 133 mg liposomal bupivacaine vs placebo was associated with improved area under the curve of pain scores (least squares mean: 136.4±12.09 vs 254.1±11.77, respectively; P <.0001), opioid consumption (least squares mean: 12.0±2.27 vs 54.3±10.05 mg, respectively; P <.0001), median time to opioid rescue (4.2 vs 0.6 hours, respectively; P <.0001), and percentage of participants not taking opioids (treatment difference, 0.166; 95% CI, 0.032–0.2; P =.008) through 48 hours. Adverse event incidence was comparable between groups.
Study limitations include the absence of comparison between the use of liposomal bupivacaine with a standard pain regimen, the lack of ultrasound assessment of phrenic nerve involvement, and the assessment of post-surgical opioid use for 72 hours only.
“[Liposomal bupivacaine] may provide a valuable therapeutic option as a long-acting single-injection local anesthetic for patients undergoing painful surgical procedures. Future studies should assess the comparative effectiveness vs multimodal analgesia with bupivacaine [hydrochloride] for major shoulder surgery.”
This study was supported by Pacira BioSciences, Inc. Please see original reference for a full list of authors’ disclosures.
Patel MA, Gadsden JC, Nedeljkovic SS, et al. Brachial plexus block with liposomal bupivacaine for shoulder surgery improves analgesia and reduces opioid consumption: results from a multicenter, randomized, double-blind, controlled trial [published online May 31, 2019]. Pain Med. doi: 10.1093/pm/pnz103