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Post-Op Lidocaine Patch

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ClinicalTrials.gov Identifier: NCT03500211
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Catherine Leclair, MD, Oregon Health and Science University

Brief Summary:
Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Lidoderm 5 % Topical Patch Other: Sham Topical Patch Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Lidoderm 5% Topical Patch
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.
Drug: Lidoderm 5 % Topical Patch
Lidocaine patch after cesarean section delivery.
Other Name: lidocaine patch

Sham Comparator: Sham Topical Patch
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.
Other: Sham Topical Patch
Sham patch after cesarean section delivery.
Other Name: sham patch




Primary Outcome Measures :
  1. 12-hour Postoperative Pain Scores [ Time Frame: Postoperative (12, 24, 36, and 48 hours) ]
    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 the Numerical Rating Scale (NVS), a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".

  2. 24-hour Postoperative Pain Scores [ Time Frame: Postoperative (24 hours) ]
    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 2 4hours postoperatively. Measured using the Numerical Rating Scale (NVS), a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".

  3. 36-hour Postoperative Pain Scores [ Time Frame: Postoperative (36 hours) ]
    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 the Numerical Rating Scale (NVS), a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".

  4. 48-hour Postoperative Pain Scores [ Time Frame: Postoperative (48 hours) ]
    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 the Numerical Rating Scale (NVS), a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".


Secondary Outcome Measures :
  1. 24-hour Postoperative Narcotic Use [ Time Frame: Postoperative (24 hours) ]
    To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of narcotic pills used in women who have undergone cesarean delivery assessed through questionnaire at 24 hours postoperatively.

  2. 48-hour Postoperative Narcotic Use [ Time Frame: Postoperative (48 hours) ]
    To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of narcotic pills used in women who have undergone cesarean delivery assessed through questionnaire at 48 hours postoperatively.

  3. 5-days Postoperative Narcotic Use [ Time Frame: Postoperative (5 days) ]
    To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of narcotic pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500211


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Catherine Leclair, MD Oregon Health and Science University

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Responsible Party: Catherine Leclair, MD, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03500211     History of Changes
Other Study ID Numbers: OHSU IRB 16657
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Catherine Leclair, MD, Oregon Health and Science University:
Cesarean section
Postoperative pain

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action