Cesarean Section Complications
Conditions
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.
Interventions
DRUGlidocaine patch
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.
DRUGIV 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.
DRUGIV 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.
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind randomized controlled study
Intervention model description
double blind randomized controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 occurrence |
| Return 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 |
Countries
Egypt
Contacts
Primary Contacthany f Sallam, md
Outcome results
None listed