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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

Primary Purpose

Opioid-use Disorder, Opioid Use, Opioid Dependence

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine patch
Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
Sponsored by
WellSpan Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • WellSpan Health York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lidoderm patch

Infusion pump

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain scores
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"

Secondary Outcome Measures

Rescue opioid consumption
Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively
Survey of nursing staff
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)
Patient survey
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)

Full Information

First Posted
July 22, 2019
Last Updated
June 3, 2021
Sponsor
WellSpan Health
Collaborators
Ambu A/S, York Opioid Collaborative, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04033562
Brief Title
The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis
Official Title
The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
limited enrollment and unable to enroll subjects to reach statistical significance
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WellSpan Health
Collaborators
Ambu A/S, York Opioid Collaborative, Pennsylvania

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound, Lidopatch, Ambu ACTion, Pregnancy Related, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidoderm patch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Infusion pump
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch
Intervention Description
Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
Intervention Type
Device
Intervention Name(s)
Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
Intervention Description
Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.
Primary Outcome Measure Information:
Title
Pain scores
Description
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"
Time Frame
post-operative until 60 hours postpartum
Secondary Outcome Measure Information:
Title
Rescue opioid consumption
Description
Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively
Time Frame
post-operative until 60 hours postpartum
Title
Survey of nursing staff
Description
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)
Time Frame
between 48-60 hours post-Cesarean delivery
Title
Patient survey
Description
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)
Time Frame
between 48-60 hourrs post-Cesarean delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Burcher, MD
Organizational Affiliation
WellSpan Health Ob-Gyn Residency Program Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
WellSpan Health York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States

12. IPD Sharing Statement

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Links:
URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071165s020lbl.pdf
Description
Bupivacaine hydrochloride
URL
http://www.endo.com/File%20Library/Products/Prescribing%20Information/LIDODERM_prescribing_information.html
Description
Lidoderm patch
URL
http://wonder.cdc.gov
Description
Wide-ranging online data for epidemiologic research (WONDER)

Learn more about this trial

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

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