Pilot Study of Liposomal Bupivacaine Redosing in Patients... | NCT04849858

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

NCT04849858

Sponsor

University of California, Irvine

Status

Terminated

Last Update Posted

Aug 23, 2024Actual

Enrollment

13Actual

Phase

Phase 3

Conditions

Ovarian Cancer
Fibroids
Uterine Cancer

Interventions

Bupivacaine
Liposomal bupivacaine
Liposomal bupivacaine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCI 19-16	Other Identifier	UCI CFCCC

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

May 20, 2019Actual

Primary Completion Date

Jan 13, 2023Actual

Completion Date

Jan 13, 2023Actual

First Submitted Date

Apr 16, 2021

First Submission Date that Met QC Criteria

Apr 16, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2024

Last Update Posted Date

Aug 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jill Tseng, Assistant Professor, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug	Participants in this group will receive a TAP block using the drug Bupivacaine.	Bupivacaine TAP Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative opioid consumption	Morphine equivalents (milligrams)	Post-operative day 0 to day 8

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

This study applies to patients receiving care with a gynecologic oncologist

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jill H Tseng, MD	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine		Orange	California	92868	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Feb 9, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 9, 2026			Feb 26, 2026	4
Mar 8, 2026

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D007889	Leiomyoma
D014594	Uterine Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

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.