Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- postoperative pain scores change on the Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.
Detailed Description
The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients 1. All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
Investigators
fatma yazıcı yılmaz
medical doctor
Sisli Hamidiye Etfal Training and Research Hospital
Eligibility Criteria
Inclusion Criteria
- •Woman having caesarean section for the first time
- •Woman, who have had no previous lower abdominal surgery
- •Woman who can give informed consent
Exclusion Criteria
- •Diabetes Mellitus (This does not include gestational diabetes)
- •Infection
- •Regular treatment with immunosuppressives
- •Alcohol or drug abuse
- •Age under 18 years old
- •Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
- •BMI over 35
Outcomes
Primary Outcomes
postoperative pain scores change on the Visual Analog Scale (VAS)
Time Frame: 1, 3 and 7 days
the difference in pain scores between two groups 1, 3 and 7 days postoperatively. Pain is registered by a score on a vas-scale from 0-10.Changes on VAS scale reported.
Secondary Outcomes
- postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus(7 days postoperatively)
- postoperative pain scores change on the Visual Analog Scale (VAS)(1and 3 months postoperatively)
- postoperative sensory loss change on skin incision scar(1and 3 months postoperatively)