Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section
- Conditions
- Cesarean Section Complications
- Interventions
- Registration Number
- NCT04505644
- Lead Sponsor
- Aswan University Hospital
- Brief Summary
To evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 180
- Female
- Primary or secondary cesarean delivery
- Able to consent to research study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lidocaine patch lidocaine patch 5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery. IV lidocaine IV lidocaine received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \>70 kg or 1 mg/min if body weight \<70 kg. IV saline infusion +Sham patch IV saline infusion +Sham patch received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
- Primary Outcome Measures
Name Time Method Total dose of opioids received in the first 24 hours following Cesarean 24 hours The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.
Post-operative pain score at 24 hours post-operatively 24 hours Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
- Secondary Outcome Measures
Name Time Method Incidence of complications of lidocaine use 72 hours Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.
Definition: Patient reported side effects which will be reported as frequencies of occurrenceReturn of bowel function 72 hours Return of bowel function (measured in hours from completion of surgery to passage of flatus) Measured in hours from completion of surgery to passage of flatus. This will be reported as a continuous variable for the number of hours following surgery to flatus
Trial Locations
- Locations (1)
Aswan University Hospital
🇪🇬Aswan, Egypt