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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849858
• Other study ID #: UCI 19-16 HS# 2019-4981
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2019
• Est. completion date: June 2022

Study information

• Verified date: June 2021
• Source: University of California, Irvine
• Contact: Jill H Tseng, MD
• Phone: 714-456-8000
• Email: jillt2[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibroids
• Leiomyoma
• Ovarian Cancer
• Ovarian Neoplasms
• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• Bupivacaine
Participants in this group will receive a TAP block using the drug Bupivacaine.
• Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.
• Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative opioid consumption	Morphine equivalents (milligrams)	Post-operative day 0 to day 8
Secondary	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
Secondary	Nausea/Vomiting	Presence or Absence of nausea or vomiting	Post-operative day 0 to day 8
Secondary	Ileus	Presence or Absence of Ileus	Post-operative day 0 to day 8
Secondary	Bowel Function	Time to return of bowel function (days)	Post-operative day 0 to day 8
Secondary	Ambulation	Time to first ambulation (days)	Post-operative day 0 to day 8
Secondary	Hospital stay	Length of hospital stay (days)	Post-operative day 0 to day 8
Secondary	Surgical Adverse Events	Presence or Absence of adverse events	Post-operative day 0 to day 8