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

Postoperative Pain Clinical Trial

— fascia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310737
• Other study ID #: 755
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: June 7, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• sharp incision
The fascia will be opened with a sharp scissors in cesarean section
• blunt incision
Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section

Locations

Country	Name	City	State
Turkey	Fatma Yazici Yilmaz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No