Comparing TAP Blocks Bupivacaine, and Placebo for Plane

NCT04685876 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20-790
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Surgery

Outcome Measures

Primary Outcomes (2)

• Total Opioids During Postoperative 24 Hours

  Opioid consumption, measured in morphine milligram equivalents, during the first 24 hours of surgery

  Postoperative 24 hours

• Total Opioid Consumption During Postoperative 24 to 48 Hours

  Total opioid consumption, in morphine milligram, equivalents, during postoperative 24 to 48 hours.

  Postoperative 24 to 48 hours

Secondary Outcomes (3)

• Time to Return of Sensation

  72 hours

• Pain Scores During Postoperative 72 Hours

  Postoperative 72 hours

• Total Opioid Consumption (Postoperative 48 to 72 Hours)

  Postoperative 48 to 72 hours

Study Arms (3)

liposomal bupivacaine

ACTIVE COMPARATOR

40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block.

Drug: Liposomal bupivacaine

plain bupivacaine

ACTIVE COMPARATOR

50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block.

Drug: Plain bupivacaine

Normal Saline

PLACEBO COMPARATOR

patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites.

Drug: Normal saline

Interventions

Liposomal bupivacaine DRUG

4-quadrant TAP block with liposomal bupivacaine

liposomal bupivacaine

Plain bupivacaine DRUG

4-quadrant TAP block with plain bupivacaine

plain bupivacaine

Normal saline DRUG

placebo (normal saline).

Normal Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Mascha: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Alparslan Turan
• Organization: University of Texas, Houston

Mehmet.A.Turan@uth.tmc.edu

713-500-6279

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Staff

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: June 4, 2021
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: August 27, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-08

Locations

US (1)