Conditions: Bowel Obstruction
Keywords: open colectomy
Allocation: NON_RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 42
Healthy volunteers: no

Brief summary:
This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Arms:
arm 1: Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. arm 2: EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.

Interventions: intervention 1: IV morphine sulfate intervention 2: EXPAREL (bupivacaine liposome injectable suspension)
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

All patients will be offered rescue analgesia, as needed.

Protocol document: