Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

Pain, Postoperative Clinical Trial

Official title:

Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959996
• Other study ID #: 2016P002307/MGH
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 8, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: May 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 3, 2017
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Scheduled cesarean delivery via Pfannenstiel incision;

2. Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.

Exclusion Criteria:

1. Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;

2. Contraindication to neuraxial anesthetic;

3. Allergy to local anesthetic;

4. Planned general anesthetic.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine
liposomal bupivacaine injection in the Pfannenstiel incision
• Placebo
placebo injection in the Pfannenstiel incision

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score With Activity	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	at 48-hours post-operatively
Secondary	Pain Score With Activity	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	at 72 -hours post-operatively
Secondary	Total Opioid Use (in Morphine Equivalents)	Total opioid use (in morphine equivalents)	72-hours post-operatively
Secondary	Satisfaction With Post-operative Pain Control	PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied	48-hours post-operatively
Secondary	Postoperative Hospital Length of Stay	Postoperative hospital length of stay	0 to 96 hours postoperatively
Secondary	Number of Patients With Wound Complication - Separation, Dehiscence, Infection	Wound complication - separation, dehiscence, infection	14 days postoperatively
Secondary	Number of Patients With Allergic Reaction Attributable to Local Anesthestic	incisional rash, hives, anaphylaxis	0-96 hours postoperatively
Secondary	Operative Time of Cesarean Delivery	Operative time of cesarean delivery	Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
Secondary	Patient Satisfaction With Pain Management at 6w Postpartum	Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used	6 weeks postpartum