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

June 15, 2021 updated by: University of California, Irvine

Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Age ≥ 18 years old
  • Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist

Exclusion Criteria

  • History of chronic pain
  • History of opioid dependence
  • Suspected or confirmed history of endometriosis
  • History of fibromyalgia
  • Suspected or confirmed interstitial cystitis or painful bladder syndrome
  • History of or current opioid use prior to surgery
  • Hypersensitivity to bupivacaine
  • Severe hepatic or renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine TAP Block
The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.
Drug: Bupivacaine
Participants in this group will receive a TAP block using the drug Bupivacaine.
ACTIVE_COMPARATOR: Liposomal Bupivacaine TAP Block
After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization
Other Names:
  • With Re-dosing
ACTIVE_COMPARATOR: Liposomal Bupivacaine TAP Block with Re-dosing
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.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization
Other Names:
  • With Re-dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative opioid consumption
Time Frame: Post-operative day 0 to day 8
Morphine equivalents (milligrams)
Post-operative day 0 to day 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Jill H Tseng, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2019

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCI 19-16 HS# 2019-4981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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