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The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

NCT04033562 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-06-07

No results posted yet for this study

Summary

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Conditions

  • Opioid-use Disorder
  • Opioid Use
  • Opioid Dependence
  • Opioid Abuse
  • Medication Assisted Treatment
  • Infusion Catheter, Wound
  • Lidopatch
  • Ambu ACTion
  • Pregnancy Related
  • Cesarean Section

Interventions

DRUG

Lidocaine patch

Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.

DEVICE

Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr

Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.

Sponsors & Collaborators

  • Ambu A/S

    collaborator INDUSTRY

  • York Opioid Collaborative, Pennsylvania

    collaborator UNKNOWN

  • WellSpan Health

    lead OTHER

Principal Investigators

  • Paul Burcher, MD · WellSpan Health Ob-Gyn Residency Program Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-05-17
Completion
2021-05-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033562 on ClinicalTrials.gov