Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial

Abstract

Background The interscalene nerve block provides analgesia for shoulder surgery. To extend block duration, provide adequate analgesia, and minimize opioid consumption, the use of adjuvants such as dexamethasone as well as the application of perineural liposomal bupivacaine have been proposed. This randomized, double-blinded, noninferiority trial hypothesized that perineural liposomal bupivacaine is noninferior to standard bupivacaine with perineural dexamethasone in respect to average pain scores in the first 72 h after surgery. Methods A total of 112 patients undergoing ambulatory shoulder surgery were randomized into two groups. The liposomal bupivacaine group received a 15-ml premixed admixture of 10 ml of 133 mg liposomal bupivacaine and 5 ml of 0.5% bupivacaine (n = 55), while the bupivacaine with dexamethasone group received an admixture of 15 ml of 0.5% standard bupivacaine with 4 mg dexamethasone (n = 56), respectively. The primary outcome was the average numerical rating scale pain scores at rest over 72 h. The mean difference between the two groups was compared against a noninferiority margin of 1.3. Secondary outcomes were analgesic block duration, motor and sensory resolution, opioid consumption, numerical rating scale pain scores at rest and movement on postoperative days 1 to 4 and again on postoperative day 7, patient satisfaction, readiness for postanesthesia care unit discharge, and adverse events. Results A liposomal bupivacaine group average numerical rating scale pain score over 72 h was not inferior to the bupivacaine with dexamethasone group (mean [SD], 2.4 [1.9] vs. 3.4 [1.9]; mean difference [95% CI], –1.1 [–1.8, –0.4]; P < 0.001 for noninferiority). There was no significant difference in duration of analgesia between the groups (26 [20, 42] h vs. 27 [20, 39] h; P = 0.851). Motor and sensory resolutions were similar in both groups: 27 (21, 48) h versus 27 (19, 40) h (P = 0.436) and 27 [21, 44] h versus 31 (20, 42) h (P = 0.862), respectively. There was no difference in opioid consumption, readiness for postanesthesia care unit discharge, or adverse events. Conclusions Interscalene nerve blocks with perineural liposomal bupivacaine provided effective analgesia similar to the perineural standard bupivacaine with dexamethasone. The results show that bupivacaine with dexamethasone can be used interchangeably with liposomal bupivacaine for analgesia after shoulder surgery. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

“…Our inability to demonstrate an improvement in opioid use postoperatively is consistent with previous work 9–11. Indeed, LB interscalene blocks have been shown to reduce opioid requirements following shoulder surgery only when compared with placebo interscalene blocks 8.…”

“…Indeed, LB interscalene blocks have been shown to reduce opioid requirements following shoulder surgery only when compared with placebo interscalene blocks 8. Our data are further evidence that the addition of LB to bupivacaine appears to not have an opioid sparing effect when compared with bupivacaine alone9 10 or with adjuvant dexamethasone11 used in interscalene block.…”

“…However, when compared with traditional bupivacaine interscalene blocks, conflicting results are reported with its addition 9 10. Recent work has demonstrated that interscalene nerve blocks using standard bupivacaine plus dexamethasone provided similar analgesia compared with LB 11…”

Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty: a randomized, non-inferiority trial

“…Other studies evaluating the efficacy of LB in interscalene block for shoulder surgery have similarly demonstrated clinically unimportant reductions in either pain scores or opioid consumption 9 15 23. When an additive such as dexamethasone is added to bupivacaine for interscalene block, the small reduction afforded by LB may become even smaller 24 25…”

Comprehensive evaluation of clinical efficiency of dexamethasone as a supportive agent for bupivacaine in spinal anesthesia

“…9 Additionally, the level of depression and anxiety must also be considered while deciding the dose of anesthetic agent for a particular age and sex. 10 Researchers have experimented various drugs to enhance the performance of the anesthesia. The popularly used adjuncts are epinephrine, opioids and ketamine.…”