NCT04680221

Brief Summary

As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 29, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

October 29, 2020

Last Update Submit

March 20, 2025

Conditions

Pain, PostoperativeOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Morphine Milligram Equivalents

    Amount of opioid medications taken converted to Morphine Milligram Equivalents

    7 days after cesarean

Secondary Outcomes (19)

  • Morphine Milligram Equivalents at 48 hours

    Time surgery is complete to 48 hours

  • Numeric Rating Scale Pain Score on postoperative day 1

    Midnight to midnight postoperative day #1

  • Time to as needed opioid use

    Inpatient stay up to 6 days

  • Opioid-spared Percentage

    Inpatient stay up to 6 days

  • Edinburgh Postpartum Depression Scale Score at Discharge

    Inpatient stay up to 6 days

  • +14 more secondary outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right.

Drug: Liposomal bupivacaineProcedure: TAP block

Control

PLACEBO COMPARATOR

The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side).

Procedure: TAP blockDrug: Deposition of saline

Interventions

Liposomal bupivacaineDRUG

Deposition of liposomal bupivacaine

Also known as: EXPAREL
Treatment
TAP blockPROCEDURE

Transversus abdominis plane block performed to deposit anesthetic

ControlTreatment
Deposition of salineDRUG

Deposition of saline

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Unlabored, scheduled primary or repeat cesarean delivery
  • Cesarean performed by obstetrician or surgically-trained family medicine physician
  • Ability to complete numeric pain scale assessment and surveys
  • Patients who do not speak English but are able to converse via an interpreter both in person and by phone

You may not qualify if:

  • Complications requiring return to the operating room
  • Unscheduled deliveries
  • \<18 years old, \>45 years old
  • Twin deliveries
  • Preterm deliveries (\<37 wks)
  • Current or previous history of opioid-substance use disorder according to patient report or medical chart
  • Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program
  • Allergy to local anesthetics or NSAIDs
  • Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher
  • Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement
  • Known significant renal disease, oliguria, or Cr \>1.1.
  • Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy
  • Infection overlying the regional anesthesia site
  • Hypovolemia prohibiting regional anesthesia
  • General anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truman Medical Center - Lakewood

Kansas City, Missouri, 64139, United States

Location

Related Publications (11)

  • Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.

    PMID: 32501202BACKGROUND

  • Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.

    PMID: 31348508BACKGROUND

  • Badreldin N, Grobman WA, Chang KT, Yee LM. Opioid prescribing patterns among postpartum women. Am J Obstet Gynecol. 2018 Jul;219(1):103.e1-103.e8. doi: 10.1016/j.ajog.2018.04.003. Epub 2018 Apr 7.

    PMID: 29630887BACKGROUND

  • Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.

    PMID: 26996986BACKGROUND

  • Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A Critical Review of Available Instruments. J Hum Lact. 2016 Feb;32(1):35-45. doi: 10.1177/0890334415599533. Epub 2015 Aug 28.

    PMID: 26319113BACKGROUND

  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PMID: 14649593BACKGROUND

  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PMID: 23411725BACKGROUND

  • Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

    PMID: 18818022BACKGROUND

  • Babazade R, Vadhera RB, Krishnamurthy P, Varma A, Doulatram G, Saade GR, Turan A. Acute postcesarean pain is associated with in-hospital exclusive breastfeeding, length of stay and post-partum depression. J Clin Anesth. 2020 Jun;62:109697. doi: 10.1016/j.jclinane.2019.109697. Epub 2019 Dec 31.

    PMID: 31899076BACKGROUND

  • Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.

    PMID: 32541292BACKGROUND

  • Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

    PMID: 18020088BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Devika Maulik, MD

    Children's Mercy Hospital Kansas City

    STUDY CHAIR

  • Gary Sutkin, MD

    University of Missouri, Kansas City

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2020

First Posted

December 22, 2020

Study Start

March 1, 2021

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)