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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Bupivacaine, Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03353363

Run by

Brooke Army Medical Center

People needed

132

Starts

2017-10-18

Expected to finish

2019-02-18

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• ASA I or II women with uncomplicated singleton pregnancies
• ≥37 weeks gestation
• ≥18 years old presenting
• Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
• Able to provide informed consent.

You may not qualify if…

• Subject is not a candidate for a spinal anesthetic
• Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)
• Subject is on chronic opioids.
• Subject is an ASA class III or higher.
• Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,
• Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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