Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Obstetric Pain
  • Opioid Use
  • Postoperative Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Single (Outcomes Assessor)Masking Description: Outcomes assessor/statistician will not be made aware of the treatment group of the patients.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 52 years
Gender
Only males

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] Ther...

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.

Tracking Information

NCT #
NCT04443569
Collaborators
Not Provided
Investigators
Principal Investigator: Audrey Merriam, MD, MS Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences