Wound Infiltration of Liposomal Bupivacaine v Plain Bupivacaine for Post-Op Pain Control in Elective Cesarean Delivery

• Status: Unknown status
• Trial end date: 2019-02-18
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brooke Army Medical Center
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. ASA I or II women with uncomplicated singleton pregnancies

2. ≥37 weeks gestation

3. ≥18 years old presenting

4. Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).

5. Able to provide informed consent.

Exclusion Criteria:

1. Subject is not a candidate for a spinal anesthetic

2. Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)

3. Subject is on chronic opioids.

4. Subject is an ASA class III or higher.

5. Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,

6. Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.