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

NCT02740114 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-10-18

Study results available
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Summary

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine.

The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.

Conditions

  • Malignant Neoplasms of Female Genital Organs
  • Gynecologic Cancer

Interventions

DRUG

Bupivacaine

150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.

DRUG

Liposomal Bupivacaine

266 mg injected on each side of the wound at the end of surgery before wound closure.

DRUG

Oxycodone

1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.

BEHAVIORAL

Pill Diary

Participants complete a pill diary every day for 30 days after hospital discharge.

BEHAVIORAL

Symptom Questionnaire

Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pedro Ramirez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-07-23
Completion
2020-07-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740114 on ClinicalTrials.gov