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

NCT04849858 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: 20194981UCI 19-16
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fibroids; Uterine Cancer

Keywords

ovarian cancer; fibroids; uterine cancer; Transverse abdominis plane block; TAP block

Outcome Measures

Primary Outcomes (1)

• Post-operative opioid consumption

  Morphine equivalents (milligrams)

  Post-operative day 0 to day 8

Secondary Outcomes (7)

• Pain at rest and during activity

  Post-operative day 0 to day 8

• Nausea/Vomiting

  Post-operative day 0 to day 8

• Ileus

  Post-operative day 0 to day 8

• Bowel Function

  Post-operative day 0 to day 8

• Ambulation

  Post-operative day 0 to day 8

Study Arms (3)

Bupivacaine TAP Block

ACTIVE COMPARATOR

The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.

Drug: Bupivacaine

Liposomal Bupivacaine TAP Block

ACTIVE COMPARATOR

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

Liposomal Bupivacaine TAP Block with Re-dosing

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

Participants in this group will receive a TAP block using the drug Bupivacaine.

Bupivacaine TAP Block

Liposomal bupivacaine DRUG

Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.

Liposomal Bupivacaine TAP Block

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study applies to patients receiving care with a gynecologic oncologist
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Leiomyoma; Uterine Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Uterine Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jill H Tseng, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective cohort study with retrospective data analysis. Patients will be assigned to treatment groups on a consecutive basis. We will be recruiting 45 eligible patients from our University of California Irvine (UCI) gynecologic oncology clinic. Each clinic patient who is scheduled for surgery will be screened for eligibility. The first 15 patients enrolled will receive perioperative plain bupivacaine transversus abdominis plane (TAP) blocks. The next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine (LB) TAP blocks. The final 15 patients enrolled will receive perioperative LB TAP blocks followed by redosing of the TAP blocks in 48-60 hours.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 19, 2021
• Study Start: May 20, 2019
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)