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

Phase 4

• Conditions: Bupivacaine; Pain, Postoperative
• Interventions: Drug: Placebos; Drug: Bupivacaine; Drug: Liposomal bupivacaine

• Registration Number: NCT03353363
• Lead Sponsor: Brooke Army Medical Center

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.

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 Timeline

• Study Start: 2017-10-18
• Status Verified: 2017-11
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-27
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-10-18
• Study Completion: 2019-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebos	Subject will receive 20ml of normal saline infiltration
Plain Bupivacaine	Bupivacaine	Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)
Liposomal Bupivacaine	Liposomal bupivacaine	Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded

Primary Outcome Measures

Name	Time	Method
Post-operative Analgesia	Thru 48 hours	VAS pain intensity scores (at rest)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States