Status:
UNKNOWN
Wound Infiltration of Liposomal Bupivacaine v Plain Bupivacaine for Post-Op Pain Control in Elective Cesarean Delivery
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Bupivacaine
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2019
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03353363
Start Date
October 18 2017
End Date
February 18 2019
Last Update
January 18 2018
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234