Phase 3
Completed N=285
Comparing TAP Blocks Bupivacaine, and Placebo for Plane
Abdominal Surgery
Source: ClinicalTrials.gov NCT04685876 ↗
Enrolled (actual)
285
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Total Opioids During Postoperative 24 Hours — 26; 33; 31 morphine milligram equivalents — p=0.355
◆ Published Evidence
Emerging
5citations · ~5 / year
Liposomal Bupivacaine, Plain Bupivacaine, and Saline for Transversus Abdominis Plane Blocks: The CLEVELAND Randomized Trial.
Summary
The study will prospectively compare the analgesic efficacy of TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients who are scheduled for major abdominal surgery. The primary aim is to assess the duration of the local analgesia (determined by pinprick and cold) in all four quadrants. Comparing opioid consumption and pain scores is a secondary aim. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.
Linked Publications
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Liposomal Bupivacaine, Plain Bupivacaine, and Saline for Transversus Abdominis Plane Blocks: The CLEVELAND Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioids During Postoperative 24 Hours |
26; 33; 31 | 0.355 |
| PRIMARY Total Opioid Consumption During Postoperative 24 to 48 Hours |
10; 19; 15 | — |
| SECONDARY Time to Return of Sensation |
0; 0; 0 | 0.248 |
| SECONDARY Pain Scores During Postoperative 72 Hours |
4; 5; 4 | 0.748 |
| SECONDARY Total Opioid Consumption (Postoperative 48 to 72 Hours) |
5; 9; 10 | 0.152 |
Eligibility Criteria
Inclusion Criteria
- Written informed consent;
- 18-85 years old;
- ASA Physical Status 1-3;
- Scheduled for elective open or laparoscopic-assisted abdominal surgery;
- Anticipated hospitalization of at least three nights;
- Expected requirement for parenteral opioids for at least 72 hours for postoperative pain;
- Able to use IV PCA systems.
Exclusion Criteria
- Hepatic disease, e.g. twice the normal levels of liver enzymes;
- Kidney disease, e.g. twice the normal level of serum creatinine;
- Bupivacaine sensitivity or known allergy;
- Women who are pregnant or breastfeeding;
- Anticoagulants considered to be a contraindication for TAP blocks;
- Surgeries with high port sites;
- Weight <50 kg.
Data sourced from ClinicalTrials.gov (NCT04685876) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.