Clinical trial NCT03353363: Wound Infiltration of Liposomal Bupivacaine v Plain Bupivacaine for Post-Op Pain Control in Elective Cesarean Delivery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bupivacaine
Pain, Postoperative
Keywords: cesarean delivery
liposomal bupivacaine
Exparel
bupivacaine
wound infiltration
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-11-27
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative Analgesia
timeFrame: Thru 24 hours
measure: Post-operative Analgesia
timeFrame: Thru 48 hours
Secondary outcomes:
measure: Opioid use in the post-operative period
timeFrame: Thru 72 hours
measure: Length of Stay (LOS)
timeFrame: Thru 72 hours
measure: Time to first ambulation
timeFrame: Thru 72 hours
measure: Breast feeding initiation
timeFrame: Thru 72 hours
measure: Sole breastfeeding
timeFrame: Thru 72 hours
measure: Increased operative time
timeFrame: Thru 72 hours
measure: Pain control at 2 hours post-cesarean delivery
timeFrame: Thru 2 hours
measure: Wound Complication
timeFrame: 14days post-operatively
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Brian M Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References: