Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2025-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

NCT04117074

Surgery Analgesia

COMPLETED PHASE3

TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

NCT02289079

Acute Pain

COMPLETED PHASE4

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

NCT04849858

Ovarian Cancer Fibroids Uterine Cancer

TERMINATED PHASE3

Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies

NCT04258631

Malignant Female Reproductive System Neoplasm

COMPLETED PHASE4

Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

NCT02740114

Malignant Neoplasms of Female Genital Organs Gynecologic Cancer

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibroid Uterus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bupivacaine TAP

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25%

normal saline

Intervention Type DRUG

10ml

Liposomal bupivacaine TAP

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

0.25%

Bupivacaine liposome

Intervention Type DRUG

10mL

normal saline

Intervention Type DRUG

10ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

0.25%

Intervention Type DRUG

Bupivacaine liposome

10mL

Intervention Type DRUG

normal saline

10ml

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Not pregnant
* Weight over 50kg presenting for open myomectomy
* No history of allergy to any study medication
* No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
* No history of drug or alcohol use or abuse disorder or pre-existing liver disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes