Post-Op Lidocaine Patch

NCT ID: NCT03500211

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2019-03-01

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidoderm 5 % Topical Patch

Intervention Type: DRUG

Lidocaine patch after cesarean section delivery.

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.

Group Type: SHAM_COMPARATOR

Sham Topical Patch

Intervention Type: OTHER

Sham patch after cesarean section delivery.

Interventions

Lidoderm 5 % Topical Patch

Lidocaine patch after cesarean section delivery.

Intervention Type: DRUG

Sham Topical Patch

Sham patch after cesarean section delivery.

Intervention Type: OTHER

Other Intervention Names

lidocaine patch; sham patch

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Catherine M Leclair, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Leclair, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OHSU IRB 16657

Identifier Type: -

Identifier Source: org_study_id