Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: sharp incision; Procedure: blunt incision

• Registration Number: NCT02310737
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

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

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-07
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sharp incision	sharp incision	the patients who were included as the control group (Group 1) with sharp fascia incision
blunt incision	blunt incision	the patients who were included as the another group (Group 2) with blunt fascia incision

Primary Outcome Measures

Name	Time	Method
postoperative pain scores change on the Visual Analog Scale (VAS)	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 Outcome Measures

Name	Time	Method
postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus	7 days postoperatively	assessment of the sensory loss difference on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus postoperatively(day7). Sensory loss measured by asking their sensory feelings on scar area, lower abdomen, pelvic region, groin, inner thigh, and labia majus
postoperative pain scores change on the Visual Analog Scale (VAS)	1and 3 months postoperatively	the difference in pain scores between two groups 1 and 3 months postoperatively. Pain is registered by a score on a vas-scale from 0-10.
postoperative sensory loss change on skin incision scar	1and 3 months postoperatively	Assessment of the sensory loss difference on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus postoperatively at 1 and 3 months. Sensory loss measured by asking their sensory feelings on scar area, lower abdomen, pelvic region, groin, inner thigh, and labia majus

Trial Locations

Locations (1)

Fatma Yazıcı Yılmaz; 🇹🇷 Istanbul, Turkey