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

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Pregnant females >18 years of age who sustained a second, third, or fourth degree laceration during a vaginal delivery, or operative vaginal delivery (forceps-assisted or vacuum-assisted) at Walter Reed National Military Medical Center

Exclusion Criteria:

• Known allergy to amide local anesthetics

• Unstable cardiac arrhythmia

• Hepatic impairment

• Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery

• Significant history of opioid or alcohol abuse or addiction (requiring treatment)

• Delivery of a fetal demise