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

NCT03353363 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: C.2017.156
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bupivacaine; Pain, Postoperative

Keywords

cesarean delivery; liposomal bupivacaine; Exparel; bupivacaine; wound infiltration

Outcome Measures

Primary Outcomes (2)

• Post-operative Analgesia

  VAS pain intensity scores (at rest)

  Thru 24 hours

• Post-operative Analgesia

  VAS pain intensity scores (at rest)

  Thru 48 hours

Secondary Outcomes (8)

• Opioid use in the post-operative period

  Thru 72 hours

• Length of Stay (LOS)

  Thru 72 hours

• Time to first ambulation

  Thru 72 hours

• Breast feeding initiation

  Thru 72 hours

• Sole breastfeeding

  Thru 72 hours

Study Arms (3)

Normal Saline

PLACEBO COMPARATOR

Subject will receive 20ml of normal saline infiltration

Drug: Placebos

Plain Bupivacaine

EXPERIMENTAL

Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)

Drug: Bupivacaine

Liposomal Bupivacaine

EXPERIMENTAL

Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded

Drug: Liposomal bupivacaine

Interventions

Bupivacaine DRUG

After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Plain Bupivacaine

Liposomal bupivacaine DRUG

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 liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Also known as: Exparel

Liposomal Bupivacaine

Placebos DRUG

After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants will include ASA I or II women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II women with uncomplicated singleton pregnancies
• ≥37 weeks gestation
• ≥18 years old presenting
• Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
• Able to provide informed consent.

You may not qualify if:

• Subject is not a candidate for a spinal anesthetic
• Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)
• Subject is on chronic opioids.
• Subject is an ASA class III or higher.
• Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,
• Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian M Fitzgerald, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian M Fitzgerald, MD

CONTACT

210-916-8666; brian.m.fitzgerald.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 27, 2017
• Study Start: October 18, 2017
• Primary Completion: October 18, 2018
• Study Completion: February 18, 2019
• Last Updated: January 18, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: By request.
• Access Criteria: By request.

Locations

US (1)