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

Brooke Army Medical Center

Status and phase: Unknown; Phase 4

Conditions: Bupivacaine; Pain, Postoperative

Treatments: Drug: Bupivacaine; Drug: Liposomal bupivacaine; Drug: Placebos

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03353363

C.2017.156

Details and patient eligibility

About

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.

Full 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 with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment.

A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. 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 of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Enrollment: 132 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

132 participants in 3 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

Subject will receive 20ml of normal saline infiltration

Treatment:

Drug: Placebos

Plain Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Liposomal Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Liposomal bupivacaine