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

A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Bupivacaine
• Intervention / Treatment: Drug: Placebos; Drug: Bupivacaine; Drug: Liposomal bupivacaine

Detailed Description

Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment.

A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. 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 of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brian M Fitzgerald, MD; Phone Number: 210-916-8666; Email: brian.m.fitzgerald.mil@mail.mil

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Brian M Fitzgerald, MD; Phone Number: 210-916-8666; Email: brian.m.fitzgerald.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. ASA I or II women with uncomplicated singleton pregnancies
2. ≥37 weeks gestation
3. ≥18 years old presenting
4. Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
5. Able to provide informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline; Subject will receive 20ml of normal saline infiltration	Drug: Placebos; 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.
Experimental: Plain Bupivacaine; Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)	Drug: Bupivacaine; 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.
Experimental: Liposomal Bupivacaine; Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded	Drug: Liposomal bupivacaine; 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.; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use in the post-operative period	Post-operative opioid consumption	Thru 72 hours
Length of Stay (LOS)	Reduction in LOS	Thru 72 hours
Time to first ambulation	Time to ambulation	Thru 72 hours
Breast feeding initiation	Time to breast feeding initiation	Thru 72 hours
Sole breastfeeding	Percentage of subjects solely breastfeeding at the time of discharge	Thru 72 hours
Increased operative time	Increased operative time for cesarean delivery	Thru 72 hours
Pain control at 2 hours post-cesarean delivery	VAS pain intensity at 2 hours	Thru 2 hours
Wound Complication	Wound complication	14days post-operatively

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Brian M Fitzgerald, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Anticipated): October 18, 2018
• Study Completion (Anticipated): February 18, 2019

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: bupivacaine; liposomal bupivacaine; cesarean delivery; wound infiltration; Exparel
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: C.2017.156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: By request.
• IPD Sharing Access Criteria: By request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No