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

A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial

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.

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.

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.