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

June 3, 2021 updated by: WellSpan Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Wellspan Health York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy
  • undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
  • Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

Exclusion Criteria:

  • Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
  • Non-English speaking
  • Allergy to bupivacaine, lidocaine, zinc, silver or menthol
  • Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
  • History of glucose-6-phosphate deficiency
  • Use of anti-arrhythmic drugs such as tocainide or mexiletine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lidoderm patch
Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.
Drug: Lidocaine patch
Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
ACTIVE_COMPARATOR: Infusion pump
Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: post-operative until 60 hours postpartum
Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"
post-operative until 60 hours postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue opioid consumption
Time Frame: post-operative until 60 hours postpartum
Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively
post-operative until 60 hours postpartum
Survey of nursing staff
Time Frame: between 48-60 hours post-Cesarean delivery
1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)
between 48-60 hours post-Cesarean delivery
Patient survey
Time Frame: between 48-60 hourrs post-Cesarean delivery
2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)
between 48-60 hourrs post-Cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Collaborators

Ambu A/S
York Opioid Collaborative, Pennsylvania

Investigators

  • Principal Investigator: Paul Burcher, MD, WellSpan Health Ob-Gyn Residency Program Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2020

Primary Completion (ACTUAL)

May 17, 2021

Study Completion (ACTUAL)

May 17, 2021

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (ACTUAL)

July 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1351850

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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