Lidocaine Patches After Cesarean Section (LPACS)
Primary Purpose
Postoperative Pain, Obstetric Pain, Opioid Use
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine patch
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lidocaine Patch Group
Control Group
Arm Description
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.
This group will be women randomized to routine postoperative pain management following cesarean delivery.
Outcomes
Primary Outcome Measures
Narcotic Use
The primary outcome of this study would be the total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents
Secondary Outcome Measures
Subjective Pain
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04443569
Brief Title
Lidocaine Patches After Cesarean Section
Acronym
LPACS
Official Title
Lidocaine Patches After Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Obstetric Pain, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine Patch Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will be women randomized to routine postoperative pain management following cesarean delivery.
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch
Intervention Description
Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
Primary Outcome Measure Information:
Title
Narcotic Use
Description
The primary outcome of this study would be the total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents
Time Frame
the first 72 hours post-operative
Secondary Outcome Measure Information:
Title
Subjective Pain
Description
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.
Time Frame
the first 72 hours post-operative, up to 4 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients need to be pregnant and undergoing a cesarean delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Merriam, MD, MS
Organizational Affiliation
Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Arkfeld, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22715181
Citation
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.
Results Reference
background
PubMed Identifier
22861076
Citation
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.
Results Reference
background
Links:
URL
https://casereports.bmj.com/content/2011/bcr.06.2010.3074
Description
Related Info
URL
http://doi.org/10.1089/lap.2018.0013
Description
Related Info
Learn more about this trial
Lidocaine Patches After Cesarean Section
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