NCT03907813

Brief Summary

The aim of this study is to determine if local wound infiltration with liposomal bupivacaine at the time of cesarean delivery can decrease opioid use and provide adequate post-operative pain control.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

April 5, 2019

Last Update Submit

July 28, 2020

Conditions

Pain, PostoperativeOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Opioid (narcotic medication) use

    total opioid use, as morphine equivalents; sum of narcotic pain medications over 48 hours reported in morphine equivalents, by the Ohio Automated RX reporting system calculator, where hydrocodone 5 mg is 5 morphine equivalent dose (MED) and percocet 5 is 7.5 MED

    at the end of 48 hours after delivery

Secondary Outcomes (2)

  • Average pain scores Day 1

    at the end of 24 hours after delivery

  • Average pain scores Day 2

    at the end of 48 hours after delivery

Study Arms (2)

liposomal bupivacaine infiltration

EXPERIMENTAL

Local infiltration of all wound layers with liposomal bupivacaine (Exparel(R)) 20 ml diluted with 70 ml of normal saline to 90 ml for patient with a BMI of 39 and under. If BMI is 40 or more the 20 ml of liposomal bupivicaine will be diluted to 150 ml by adding 130 ml of normal saline

Drug: Exparel

Saline infiltration

PLACEBO COMPARATOR

Local infiltration of all wound layers with saline, using to match the amount. The amount of total fluid is divided into 4 and instilled with 1-2 ml at a time in between fascial layers after fascial closure. Each 1/4 will be instilled laterally (2) and on each side of the incision(2)- extra fluid is placed subcutaneously.

Other: Saline infiltration

Interventions

ExparelDRUG

liposomal bupivacaine wound infiltration

Also known as: liposomal bupivacaine
liposomal bupivacaine infiltration
Saline infiltrationOTHER

saline wound infiltration

Saline infiltration

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women delivering by scheduled cesarean delivery
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are between 18 and 45 years of age, inclusive.
  • Are undergoing a planned, primary or repeat, cesarean delivery without permanent sterilization.
  • Have a BMI ≤ 60.
  • Are able to read and understand English.

You may not qualify if:

  • Have pre-eclampsia with severe features.
  • Has been taking medication assisted treatment for opioid addiction during this pregnancy.
  • Have known sensitivity to local anesthetic.
  • Have a known sensitivity to non-steroidal anti-inflammatory medications.
  • Planning to have a tubal ligation after the cesarean delivery.
  • Are unable to receive neuraxial analgesia and/or Duramorph, a morphine formulation that is the standard of care for intrathecal anesthesia at MVH.
  • Are prisoners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Related Publications (8)

  • Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.

    PMID: 19588413BACKGROUND

  • Bamigboye AA, Justus HG. Ropivacaine abdominal wound infiltration and peritoneal spraying at cesarean delivery for preemptive analgesia. Int J Gynaecol Obstet. 2008 Aug;102(2):160-4. doi: 10.1016/j.ijgo.2008.03.019. Epub 2008 Jun 9.

    PMID: 18538773BACKGROUND

  • Gasanova I, Alexander J, Ogunnaike B, Hamid C, Rogers D, Minhajuddin A, Joshi GP. Transversus Abdominis Plane Block Versus Surgical Site Infiltration for Pain Management After Open Total Abdominal Hysterectomy. Anesth Analg. 2015 Nov;121(5):1383-8. doi: 10.1213/ANE.0000000000000909.

    PMID: 26252171BACKGROUND

  • Kalogera E, Bakkum-Gamez JN, Weaver AL, Moriarty JP, Borah BJ, Langstraat CL, Jankowski CJ, Lovely JK, Cliby WA, Dowdy SC. Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. Obstet Gynecol. 2016 Nov;128(5):1009-1017. doi: 10.1097/AOG.0000000000001719.

    PMID: 27741199BACKGROUND

  • Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.

    PMID: 23049275BACKGROUND

  • Sammour T, Kahokehr A, Soop M, Hill AG. Peritoneal damage: the inflammatory response and clinical implications of the neuro-immuno-humoral axis. World J Surg. 2010 Apr;34(4):704-20. doi: 10.1007/s00268-009-0382-y.

    PMID: 20049432BACKGROUND

  • Yaklic JL; Maxwell RA; Urschel K; Robinson S; Dearmond MK; Lindheim SR Effect of Continuous Local Anesthetic Use for Pain Control and Narcotic Use After Cesarean Section: A Randomized Trial. Open J Surg. 2017; 1(1): 026-030

    BACKGROUND

  • State of Ohio Board of Pharmacy 2019. OARRS Rules Update - Spring 2019; Rules Update - Drug Distributors - Spring 2019; Rules Update - Terminal Distributors - Spring 2019; 2018. 2nd and 3rd Quarter - Rule Update pharmacy.ohio.gov

    BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Marilyn Kindig, DO

    Wright State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, double blind trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

May 1, 2019

Primary Completion

June 30, 2020

Study Completion

July 31, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Data will be shared on a case by case basis.

Locations

US(1)