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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02310737
Acronym
fascia
Enrollment
123
Registered
2014-12-08
Start date
2014-09-30
Completion date
2015-03-31
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

cesarean section, facial incision, postoperative pain

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

Interventions

PROCEDUREsharp incision

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

PROCEDUREblunt incision

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

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain scores change on the Visual Analog Scale (VAS)1, 3 and 7 daysthe 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

MeasureTime frameDescription
postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus7 days postoperativelyassessment 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 postoperativelythe 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 scar1and 3 months postoperativelyAssessment 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026