Clinical trial NCT04849858: Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures
Official title: Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ovarian Cancer
Fibroids
Uterine Cancer
Keywords: ovarian cancer
fibroids
uterine cancer
Transverse abdominis plane block
TAP block
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative opioid consumption
timeFrame: Post-operative day 0 to day 8
Secondary outcomes:
measure: Pain at rest and during activity
timeFrame: Post-operative day 0 to day 8
measure: Nausea/Vomiting
timeFrame: Post-operative day 0 to day 8
measure: Ileus
timeFrame: Post-operative day 0 to day 8
measure: Bowel Function
timeFrame: Post-operative day 0 to day 8
measure: Ambulation
timeFrame: Post-operative day 0 to day 8
measure: Hospital stay
timeFrame: Post-operative day 0 to day 8
measure: Surgical Adverse Events
timeFrame: Post-operative day 0 to day 8
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Jill H Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References: