Lidocaine Patches After Cesarean Section

NCT04443569 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2000028500
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the impact of using lidocaine patches after cesarean section on pain control and opioid use in the immediate post-operative period. The hypothesis is the use of lidocaine patches in the immediate post-operative period will lead to a decrease in the visual analog pain score compared to women who do not use a lidocaine patch in the immediate post-operative period following cesarean delivery. Additionally, a decrease in the use of opioids as pain control compared to patients that do not have a lidocaine patch in place the is anticipated.

Conditions

Postoperative Pain; Obstetric Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score

  Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain.

  the first 72 hours post-operative, up to 4 days

Secondary Outcomes (1)

• Narcotic Use

  the first 72 hours post-operative

Study Arms (2)

Lidocaine Patch Group

EXPERIMENTAL

This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.

Drug: Lidocaine patch

Control Group

PLACEBO COMPARATOR

This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.

Other: Placebo patch

Interventions

Lidocaine patch DRUG

Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management

Lidocaine Patch Group

Placebo patch OTHER

A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.

Control Group

Eligibility Criteria

• Age: 18 Years - 52 Years
• Gender Eligibility Details: Patients need to be pregnant and undergoing a cesarean delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Primary or secondary cesarean delivery
• Able to consent to research study

You may not qualify if:

• or more prior cesarean deliveries
• History of abdominoplasty
• History of abdominal hernia repair with mesh
• Allergy to lidocaine
• Allergy to adhesives in medical tape
• Women who received general anesthesia for their cesarean delivery
• Women with active substance abuse
• Women methadone or suboxone for a history of opiate abuse

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Related Publications (2)

• Gilhooly D, McGarvey B, O'Mahony H, O'Connor TC. Topical lidocaine patch 5% for acute postoperative pain control. BMJ Case Rep. 2011 Feb 8;2011:bcr0620103074. doi: 10.1136/bcr.06.2010.3074.

  PMID: 22715181 BACKGROUND

• Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.

  PMID: 22861076 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative; Labor Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Christopher Arkfeld
• Organization: Massachusetts General Hospital

carkfeld@mgh.harvard.edu

4029803860

Study Officials

• Audrey Merriam, MD, MS

  Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

  PRINCIPAL INVESTIGATOR

• Christopher Arkfeld, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: October 10, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 6, 2024
• Results First Posted: October 10, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)