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LPACS: Lidocaine Patches After Cesarean Section

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04443569
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
12.7
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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 use of opioids as pain control compared to patients that do not have a lidocaine patch in place. Additionally, the 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 is anticipated.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine patch
 N/A

Detailed Description

The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature.[1] There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale . [2] There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.

Cesarean sections are one of the most common surgeries in the United States. Following cesarean sections it is common to utilize opioids in the hospital and upon discharge to manage patient's post-operative pain. According to the CDC overdose deaths involving prescription opioids were five times higher in 2017 than in 1999 with over 200,000 deaths.[3] This creates an opportunity to decrease the use of post-operative opioids with the application of a lidocaine patch as an adjunctive post-operative pain management modality following cesarean sections.

Lidocaine patches are a common topical analgesia therapy used for localized pain control in the inpatient and outpatient setting. It's use in the postoperative period is less understood and the use of topical lidocaine patches has not been thoroughly investigated in the surgical literature. Thus far, it has been shown as an effective therapy at laparoscopic port sites following laparoscopic appendectomies. [4] It's use in obstetrical surgeries has not been studied. Overall, the limited research on this topic making it a valuable area of research.

This study will involve prospective enrollment of women undergoing cesarean deliveries. Women will be randomized to receive a lidocaine patch or no lidocaine patch to be worn for 72 hours after delivery to help manage postoperative pain. This will be an adjunctive therapy in addition to the parental and oral narcotic pain medication that is routine prescribed. The utility of lidocaine patches for management of post-cesarean delivery pain will be assess by 2 measures. The first measure will involve the total daily dose of narcotic used in morphine equivalent doses. The second outcome assessed will be subjective pain as measured on a 1-10 scale and reported by the patients to nursing staff. This score will be averaged for each 24 hour period post-operatively.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
Primary Purpose:
Treatment
Official Title:
Lidocaine Patches After Cesarean Section
Actual Study Start Date :
Oct 10, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine Patch Group

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
Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
No Intervention: Control Group

This group will be women randomized to routine postoperative pain management following cesarean delivery.

Outcome Measures

Primary Outcome Measures

  1. Narcotic use [the first 72 hours post-operative]

    The primary outcome of this study would be the total amount of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents

Secondary Outcome Measures

  1. Subjective Pain [the first 72 hours post-operative]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 52 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Female

  • Primary or secondary cesarean delivery

  • Able to consent to research study

Exclusion Criteria:

  • 3 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale New Haven Hospital New Haven Connecticut United States 06512

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Audrey Merriam, MD, MS, Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04443569
Other Study ID Numbers:
  • 2000028500
First Posted:
Jun 23, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Labor Pain
Lidocaine

Study Results

No Results Posted as of Feb 24, 2022