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Comparing TAP Blocks Bupivacaine, and Placebo for Plane
Phase 3 trial testing Liposomal bupivacaine in Abdominal Surgery in 285 participants. Completed in 20 February 2024.
| Lead sponsor | Edward Mascha |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 285 |
| Start date | 4 June 2021 |
| Primary completion | 20 February 2024 |
| Estimated completion | 20 February 2024 |
| Sites | 1 location across United States |
Edward Mascha
Adults 18 to 85, any sex, with Abdominal Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Opioid consumption, measured in morphine milligram equivalents, during the first 24 hours of surgery
| Group | Value | 95% CI |
|---|---|---|
| Liposomal Bupivacaine | 26 | 18 – 48 |
| Plain Bupivacaine | 33 | 13 – 75 |
| Normal Saline | 31 | 17 – 53 |
Total opioid consumption, in morphine milligram, equivalents, during postoperative 24 to 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Liposomal Bupivacaine | 10 | 2 – 25 |
| Plain Bupivacaine | 19 | 5 – 42 |
| Normal Saline | 15 | 5 – 27 |
The investigator evaluate when patients feels both ice and pinprick in at least 6 of the 8 designated test locations, or 75% of the covered points if the TAP block did not initially cover all eight locations. The outcome is time (days) until sensation is recovered in 75% of the covered points.
| Group | Value | 95% CI |
|---|---|---|
| Liposomal Bupivacaine | 0 | 0 – 0 |
| Plain Bupivacaine | 0 | 0 – 0 |
| Normal Saline | 0 | 0 – 0 |
Pain scores measured using the numeric rating scale (NRS) going from 0 to 10, with 0 representing least pain and 10 representing most pain.
| Group | Value | 95% CI |
|---|---|---|
| Liposomal Bupivacaine | 4 | 3 – 6 |
| Plain Bupivacaine | 5 | 3 – 6 |
| Normal Saline | 4 | 3 – 5 |
Total opioid consumption, in morphine milligram equivalents, during postoperative 48 to 72 hours.
| Group | Value | 95% CI |
|---|---|---|
| Liposomal Bupivacaine | 5 | 0 – 15 |
| Plain Bupivacaine | 9 | 1 – 26 |
| Normal Saline | 10 | 0 – 18 |
Time frame: Until discharge (approximately 5 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Liposomal Bupivacaine | Plain Bupivacaine | Normal Saline |
|---|---|---|---|---|
| Opioid related side effects | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT04685876 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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