Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Postoperative Pain Clinical Trial

Official title:

Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02581293
• Other study ID #: 31/2015
• Status: Recruiting
• Phase: Phase 1
• First received: September 16, 2015
• Last updated: October 19, 2015
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Meryem Kurek EKEN, MD
• Phone: +905305104468
• Email: meryemkurek[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.

Description:

At c-section subject will be randomised into four groups:

Group1: Only visceral peritoneum will be closed

Group 2: Only parietal peritoneum will be closed

Group 3: Both of them will be closed

Group 4: None of them will be closed

During the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• Women underwent uncomplicated c-section

Exclusion Criteria:

• Patient with systemic Diseases

• Pregnant with Obstetric complications

• Pregnant with two or more previous c-sections

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Group 1: Only visceral peritoneum will be closed

• Group 2 : Only parietal peritoneum will be closed

• Group 3 : Both of them will be closed

• Group 4: None of them will be closed

Locations

Country	Name	City	State
Turkey	Meryem Kurek EKEN	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative vital sign (arterial tension)		First postoperative hour	Yes