Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

Phase 3

Terminated

• Conditions: Uterine Cancer; Fibroids; Ovarian Cancer
• Interventions: Drug: Bupivacaine; Drug: Liposomal bupivacaine

• Registration Number: NCT04849858
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

Detailed Description

The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.

Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.

Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-19
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Bupivacaine TAP Block	Bupivacaine	The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.
Liposomal Bupivacaine TAP Block with Re-dosing	Liposomal bupivacaine	After enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours.
Liposomal Bupivacaine TAP Block	Liposomal bupivacaine	After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.

Primary Outcome Measures

Name	Time	Method
Post-operative opioid consumption	Post-operative day 0 to day 8	Morphine equivalents (milligrams)

Secondary Outcome Measures

Name	Time	Method
Bowel Function	Post-operative day 0 to day 8	Time to return of bowel function (days)
Pain at rest and during activity	Post-operative day 0 to day 8	Measured pain on a Visual Analog Scale (VAS), Scale 0 (no pain) - 10 (high pain)
Nausea/Vomiting	Post-operative day 0 to day 8	Presence or Absence of nausea or vomiting
Hospital stay	Post-operative day 0 to day 8	Length of hospital stay (days)
Ileus	Post-operative day 0 to day 8	Presence or Absence of Ileus
Ambulation	Post-operative day 0 to day 8	Time to first ambulation (days)
Surgical Adverse Events	Post-operative day 0 to day 8	Presence or Absence of adverse events

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Orange, California, United States