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Completed

NCT Number: NCT04443569

Lidocaine Patches After Cesarean Section

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.

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Key information

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

About this study

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. 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. 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. 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine patch

Drug

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

Placebo patch

Other

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

Primary outcomes

  1. Visual Analog Pain Score

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

    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.

Secondary outcomes

  1. Narcotic Use

    Time frame: the first 72 hours post-operative

    The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: LPACS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2020
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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