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

Sisli Hamidiye Etfal Training and Research Hospital123 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

123

Conditions

Postoperative Pain

Interventions

sharp incisionPROCEDURE

The fascia will be opened with a sharp scissors in cesarean section

blunt incisionPROCEDURE

Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fatma Yazıcı Yılmaz

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 1, 3 and 7 days

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 1and 3 months postoperatively

Data from ClinicalTrials.gov

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