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

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: Terminated
• Conditions: Ovarian Cancer; Uterine Cancer; Fibroids
• Intervention / Treatment: Drug: Bupivacaine; Drug: Liposomal bupivacaine; Drug: Liposomal bupivacaine

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 (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

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): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ovarian cancer; fibroids; TAP block; uterine cancer; Transverse abdominis plane block
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Neoplasms, Muscle Tissue; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Leiomyoma; Uterine Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 20194981; UCI 19-16 (Other Identifier: UCI CFCCC)

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