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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
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.
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.
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.
Aswan University Hospital
Aswān, Egypt
Total dose of opioids received in the first 24 hours following Cesarean
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.
Time frame: 24 hours
Post-operative pain score at 24 hours post-operatively
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
Time frame: 24 hours
Incidence of complications of lidocaine use
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 occurrence
Time frame: 72 hours
Return of bowel function
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
Time frame: 72 hours
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