Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Jill H Tseng, MD

Description

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.

Official Title

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

Details

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.

Keywords

Ovarian Cancer Fibroids Uterine Cancer Transverse abdominis plane block TAP block Ovarian Neoplasms Leiomyoma Uterine Neoplasms Bupivacaine Liposomal bupivacaine Bupivacaine TAP Block Liposomal Bupivacaine TAP Block

Eligibility

You can join if…

Open to females ages 18 years and up

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

You CAN'T join 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

Location

  • University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Jill H Tseng, MD
    Assistant Health Sciences Professor, Obstetrics and Gynecology. Authored (or co-authored) 18 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04849858
Phase
Phase 3
Study Type
Interventional
Last Updated