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Completed

NCT Number: NCT02310737

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Yazıcı Yılmaz

Istanbul, 34371, Turkey (Türkiye)

About this study

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

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sharp incision

Procedure

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

blunt incision

Procedure

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

Primary outcomes

  1. postoperative pain scores change on the Visual Analog Scale (VAS)

    Time frame: 1, 3 and 7 days

    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.

Secondary outcomes

  1. postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus

    Time frame: 7 days postoperatively

    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

  2. postoperative pain scores change on the Visual Analog Scale (VAS)

    Time frame: 1and 3 months postoperatively

    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.

  3. postoperative sensory loss change on skin incision scar

    Time frame: 1and 3 months postoperatively

    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

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: fascia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2014
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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