Recruiting

Liposomal Bupivacaine vs. Bupivacaine

Sponsor:

Brooke Army Medical Center

Code:

NCT03353363

Conditions

Bupivacaine

Pain, Postoperative

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Bupivacaine

Liposomal bupivacaine

Placebos

Study Details

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 presenting for elective caesarean delivery.

Conditions

Bupivacaine

Pain, Postoperative

Study ID

NCT03353363

Start date

Oct 18, 2017

Status verified date

Nov, 2017

Completion date

Feb 18, 2019

Anticipated

Primary completion date

Oct 18, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Normal Saline

Subject will receive 20ml of normal saline infiltration

experimental: Plain Bupivacaine

Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)

experimental: Liposomal Bupivacaine

Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded

Interventions

Bupivacaine

After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Liposomal bupivacaine

After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Placebos

After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Primary outcome measure

  • Post-operative Analgesia [ Time Frame: Thru 24 hours ]
  • Post-operative Analgesia [ Time Frame: Thru 48 hours ]

Central Contacts and Locations

Central contacts

Brian M Fitzgerald, MD

210-916-8666brian.m.fitzgerald.mil@mail.mil

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Brian M Fitzgerald, MD

210-916-8666brian.m.fitzgerald.mil@mail.mil

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Jan 18, 2018

Last verified

Nov, 2017

Keywords

  • cesarean delivery
  • liposomal bupivacaine
  • Exparel
  • bupivacaine
  • wound infiltration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2018-01-18.