Lidocaine Patches After Cesarean Section

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Dexamethasone on Post-Cesarean Pain

NCT04067609

Post-Cesarean Pain Cesarean Section Complications

COMPLETED PHASE4

Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections

NCT06433713

Postoperative Pain Postoperative Return of Bowel Function

COMPLETED PHASE2

Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine

NCT04369950

Physiological Effect of Drugs Morphine Analgesics +3 more

COMPLETED PHASE4

Comparison of the Application of Lidocaine With Intraperitoneal Bupivacaine in Cesarian Operations Wound Infiltration

NCT04856735

Postoperative Pain Cesarean Section

UNKNOWN NA

Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

NCT02707081

Postcesarean Pain Relief

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Obstetric Pain Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor/statistician will not be made aware of the treatment group of the patients.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lidocaine patch

Intervention Type DRUG

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

Control Group

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.

Group Type PLACEBO_COMPARATOR

Placebo patch

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine patch

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

Intervention Type DRUG

Placebo patch

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes