Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision
fascia
1 other identifier
interventional
123
1 country
1
Brief Summary
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Sep 2014
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 9, 2015
June 1, 2015
6 months
November 14, 2014
June 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
7 days postoperatively
postoperative pain scores change on the Visual Analog Scale (VAS)
1and 3 months postoperatively
postoperative sensory loss change on skin incision scar
1and 3 months postoperatively
Study Arms (2)
sharp incision
ACTIVE COMPARATORthe patients who were included as the control group (Group 1) with sharp fascia incision
blunt incision
ACTIVE COMPARATORthe patients who were included as the another group (Group 2) with blunt fascia incision
Interventions
The fascia will be opened with a sharp scissors in cesarean section
Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section
Eligibility Criteria
You may qualify if:
- Woman having caesarean section for the first time
- Woman, who have had no previous lower abdominal surgery
- Woman who can give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatma Yazıcı Yılmaz
Istanbul, 34371, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
fatma yazıcı yılmaz, md
sisli etfal training research and hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
November 14, 2014
First Posted
December 8, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 9, 2015
Record last verified: 2015-06