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

PHASE3TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

July 23, 2020

Study Completion Date

July 23, 2020

Conditions
Malignant Neoplasms of Female Genital OrgansGynecologic 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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT02740114 - Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway | Biotech Hunter | Biotech Hunter