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

Study Overview
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Brief Summary
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The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.

Detailed Description
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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

Official Title
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Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: sharp incision
* Procedure: blunt incision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sharp incision<br>the patients who were included as the control group (Group 1) with sharp fascia incision | Procedure: sharp incision<br>* The fascia will be opened with a sharp scissors in cesarean section<br>|
| Active Comparator: blunt incision<br>the patients who were included as the another group (Group 2) with blunt fascia incision | Procedure: blunt incision<br>* Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain scores change on the Visual Analog Scale (VAS) | 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. | 1, 3 and 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus | 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 | 7 days postoperatively | 
| postoperative pain scores change on the Visual Analog Scale (VAS) | 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. | 1and 3 months postoperatively | 
| postoperative sensory loss change on skin incision scar | 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 | 1and 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, facial incision, postoperative pain