Liposomal Bupivacaine, Plain Bupivacaine, and Saline for Transversus Abdominis Plane Blocks: The CLEVELAND Randomized Trial.
Summary
In this randomized, blinded trial (n=261), single-shot four-quadrant TAP blocks with liposomal bupivacaine, plain bupivacaine, or saline produced similar opioid requirements and pain scores at 24, 48, and 72 hours after major abdominal surgery. The findings indicate no early or sustained analgesic benefit from liposomal bupivacaine or plain bupivacaine versus placebo when used in this context.
Key Findings
- 24-hour opioid consumption was similar across groups: liposomal bupivacaine 26 [18,48] MME, plain bupivacaine 33 [13,75] MME, placebo 31 [17,53] MME.
- Geometric mean ratios showed no reduction with liposomal (0.86; 97.7% CI 0.60–1.24) or plain bupivacaine (0.91; 97.7% CI 0.63–1.32) versus placebo.
- Opioid use from 24–48 hours, 48–72 hours, pain scores, time to return of sensation, and other secondary outcomes were comparable among all groups.
Clinical Implications
Avoid routine pre-incision, single-shot TAP blocks in mixed major abdominal surgery populations and reconsider the use of costly liposomal bupivacaine. Emphasize multimodal systemic analgesia and consider alternative regional techniques (e.g., continuous catheters) where indicated.
Why It Matters
This well-powered negative RCT challenges the routine use of pre-incision single-shot TAP blocks and the perceived advantages of liposomal bupivacaine, with substantial implications for ERAS pathways and cost-effective perioperative care.
Limitations
- Heterogeneous surgical population and procedures may dilute subgroup benefits
- Single-shot, pre-incision strategy; findings may not apply to continuous catheter techniques or postoperative timing
Future Directions
Evaluate patient selection, timing (postoperative vs pre-incision), and continuous catheter techniques; cost-effectiveness analyses to guide de-implementation and resource allocation.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, blinded controlled trial with adequate sample size
- Study Design
- OTHER