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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353363
• Other study ID #: C.2017.156
• Status: Recruiting
• Phase: Phase 4
• First received: November 16, 2017
• Last updated: January 16, 2018
• Start date: October 18, 2017
• Est. completion date: February 18, 2019

Study information

• Verified date: November 2017
• Source: Brooke Army Medical Center
• Contact: Brian M Fitzgerald, MD
• Phone: 210-916-8666
• Email: brian.m.fitzgerald.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 18, 2019
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bupivacaine
• Pain, Postoperative

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Analgesia	VAS pain intensity scores (at rest)	Thru 24 hours
Primary	Post-operative Analgesia	VAS pain intensity scores (at rest)	Thru 48 hours
Secondary	Opioid use in the post-operative period	Post-operative opioid consumption	Thru 72 hours
Secondary	Length of Stay (LOS)	Reduction in LOS	Thru 72 hours
Secondary	Time to first ambulation	Time to ambulation	Thru 72 hours
Secondary	Breast feeding initiation	Time to breast feeding initiation	Thru 72 hours
Secondary	Sole breastfeeding	Percentage of subjects solely breastfeeding at the time of discharge	Thru 72 hours
Secondary	Increased operative time	Increased operative time for cesarean delivery	Thru 72 hours
Secondary	Pain control at 2 hours post-cesarean delivery	VAS pain intensity at 2 hours	Thru 2 hours
Secondary	Wound Complication	Wound complication	14days post-operatively