MedTrace Logo

Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration

NCT03152877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-07-15

No results posted yet for this study

Summary

We propose a prospective, randomized, single blinded trial with subjects recruited from the WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in patients undergoing a vaginal delivery who sustained a second, third, or fourth degree obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the study will be consented upon admission for active labor or induction of labor and will be randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain bupivacaine, infiltrated through the perineum at completion of their obstetrical repair. Current standard of care is to receive no injection of local anesthetic upon completion of the repair.

The primary aim of the trial will be to evaluate post-partum pain using a visual analogue pain scale at days 1, 3 and 7 postpartum. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual post-partum pain control regimen.

We anticipate a 30% difference in post-operative pain measurements between the Exparel® group and the plain bupivacaine group. Other aims of this study are to evaluate total medication usage, comparing the study group to the control, and compare quality of life measures between the two study groups.

Conditions

  • Pain, Obstetric

Interventions

DRUG

Bupivacaine Liposome Injectable Product

20cc of liposomal bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.

DRUG

0.25% plain bupivacaine

20cc of 0.25% plain bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Christopher J Strauchon, DO · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT03152877 on ClinicalTrials.gov