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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

Sponsor
WellSpan Health (Other)
Overall Status
Terminated
CT.gov ID
NCT04033562
Collaborator
Ambu A/S (Industry), York Opioid Collaborative, Pennsylvania (Other)
2
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine patch
  • Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
May 17, 2021
Actual Study Completion Date :
May 17, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain scores [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"

Secondary Outcome Measures

  1. Rescue opioid consumption [post-operative until 60 hours postpartum]

    Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively

  2. Survey of nursing staff [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)

  3. Patient survey [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WellSpan Health York Hospital York Pennsylvania United States 17403

Sponsors and Collaborators

  • WellSpan Health
  • Ambu A/S
  • York Opioid Collaborative, Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
WellSpan Health
ClinicalTrials.gov Identifier:
NCT04033562
Other Study ID Numbers:
  • 1351850
First Posted:
Jul 26, 2019
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021
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
Additional relevant MeSH terms:
Opioid-Related Disorders
Lidocaine
Bupivacaine

Study Results

No Results Posted as of Jun 7, 2021