Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

Phase 2

Completed

Conditions: Pain, Postoperative

Interventions: Drug: Placebo
Drug: Liposomal bupivacaine

Registration Number: NCT02959996

Lead Sponsor: Massachusetts General Hospital

Brief Summary: This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores.

Detailed Description: This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).

The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.

Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.

The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Scheduled cesarean delivery via Pfannenstiel incision;
Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.

Exclusion Criteria

Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
Contraindication to neuraxial anesthetic;
Allergy to local anesthetic;
Planned general anesthetic.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline will be infiltrated
Intervention	Liposomal bupivacaine	Liposomal bupivacaine will be infiltrated

Primary Outcome Measures

Name	Time	Method
Pain Score With Activity	at 48-hours post-operatively	Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39

Secondary Outcome Measures

Name	Time	Method
Pain Score With Activity	at 72 -hours post-operatively	Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment
Total Opioid Use (in Morphine Equivalents)	72-hours post-operatively	Total opioid use (in morphine equivalents)
Satisfaction With Post-operative Pain Control	48-hours post-operatively	PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied
Postoperative Hospital Length of Stay	0 to 96 hours postoperatively	Postoperative hospital length of stay
Number of Patients With Wound Complication - Separation, Dehiscence, Infection	14 days postoperatively	Wound complication - separation, dehiscence, infection
Number of Patients With Allergic Reaction Attributable to Local Anesthestic	0-96 hours postoperatively	incisional rash, hives, anaphylaxis
Operative Time of Cesarean Delivery	Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.	Operative time of cesarean delivery
Patient Satisfaction With Pain Management at 6w Postpartum	6 weeks postpartum	Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used