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Post-Op Lidocaine Patch

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidoderm 5 % Topical Patch
Sham Topical Patch
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Cesarean section, Postoperative pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant patients who require a scheduled or non-urgent cesarean birth
  • Patient able to receive neuraxial analgesia
  • Patient able to give verbal and written consent for both cesarean birth and study

Exclusion Criteria:

  • Patients requiring emergent cesarean birth
  • Patients allergic to lidocaine or adhesive
  • Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
  • Patients using chronic oral neuromodulators
  • Patients with cardiac disease or using anti-arrhythmic agents
  • Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
  • Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lidoderm 5% Topical Patch

Sham Topical Patch

Arm Description

5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Outcomes

Primary Outcome Measures

12-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
24-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
36-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
48-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Secondary Outcome Measures

5-days Postoperative Narcotic Use
To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.

Full Information

First Posted
April 9, 2018
Last Updated
March 5, 2020
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03500211
Brief Title
Post-Op Lidocaine Patch
Official Title
Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.
Detailed Description
The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Cesarean section, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidoderm 5% Topical Patch
Arm Type
Experimental
Arm Description
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Arm Title
Sham Topical Patch
Arm Type
Sham Comparator
Arm Description
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Intervention Type
Drug
Intervention Name(s)
Lidoderm 5 % Topical Patch
Other Intervention Name(s)
lidocaine patch
Intervention Description
Lidocaine patch after cesarean section delivery.
Intervention Type
Other
Intervention Name(s)
Sham Topical Patch
Other Intervention Name(s)
sham patch
Intervention Description
Sham patch after cesarean section delivery.
Primary Outcome Measure Information:
Title
12-hour Postoperative Pain Scores
Description
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Time Frame
Postoperative (12 hours)
Title
24-hour Postoperative Pain Scores
Description
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Time Frame
Postoperative (24 hours)
Title
36-hour Postoperative Pain Scores
Description
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Time Frame
Postoperative (36 hours)
Title
48-hour Postoperative Pain Scores
Description
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Time Frame
Postoperative (48 hours)
Secondary Outcome Measure Information:
Title
5-days Postoperative Narcotic Use
Description
To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.
Time Frame
Postoperative (5 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant patients who require a scheduled or non-urgent cesarean birth Patient able to receive neuraxial analgesia Patient able to give verbal and written consent for both cesarean birth and study Exclusion Criteria: Patients requiring emergent cesarean birth Patients allergic to lidocaine or adhesive Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth Patients using chronic oral neuromodulators Patients with cardiac disease or using anti-arrhythmic agents Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus. Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Leclair, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-Op Lidocaine Patch

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