Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

NCT02959996 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2016P002307/MGH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Score With Activity

  at 72 -hours post-operatively

• Total Opioid Use (in Morphine Equivalents)

  72-hours post-operatively

• Satisfaction With Post-operative Pain Control

  48-hours post-operatively

• Postoperative Hospital Length of Stay

  0 to 96 hours postoperatively

• Number of Patients With Wound Complication - Separation, Dehiscence, Infection

  14 days postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline will be infiltrated

Drug: Placebo

Intervention

ACTIVE COMPARATOR

Liposomal bupivacaine will be infiltrated

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

liposomal bupivacaine injection in the Pfannenstiel incision

Also known as: Exparel

Intervention

Placebo DRUG

placebo injection in the Pfannenstiel incision

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Prabhu M, Clapp MA, McQuaid-Hanson E, Ona S, O'Donnell T, James K, Bateman BT, Wylie BJ, Barth WH Jr. Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):70-78. doi: 10.1097/AOG.0000000000002649.

  PMID: 29889750 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Malavika Prabhu
• Organization: Massachussetts General Hospital

mprabhu@mgh.harvard.edu

6177249028

Study Officials

• William H Barth, Jr, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 9, 2016
• Study Start: March 8, 2017
• Primary Completion: September 25, 2017
• Study Completion: November 3, 2017
• Last Updated: August 27, 2018
• Results First Posted: August 27, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)