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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: sharp incision; Procedure: blunt incision

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Fatma Yazıcı Yılmaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: fatma yazıcı yılmaz, md, sisli etfal training research and hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 7, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: cesarean section; postoperative pain; facial incision
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 755