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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06403540
Other study ID # 02fg
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date July 30, 2024

Study information

Verified date May 2024
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact fethi gültop
Phone +905052260067
Email fethigultop@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Major abdominal surgeries are traditionally performed via laparotomy. Analgesia is routinely administered during the postoperative period. The goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function.


Description:

Laparotomy is typically performed through a midline incision during major abdominal surgeries. Patients have difficulty breathing deeply after surgery, particularly because of pain. Intravenous drug administration, epidural catheter placement, and abdominal plane blocks are common methods of analgesia. In this study, the investigators will measure the diaphragm muscle thickness at the xiphoid level at the anterior axillary line in the supine position in participants who underwent laparotomy before and one hour after the operation, using ultrasonography M mode during inspiration, expiration, and forced inspiration. the investigators will test the effects of analgesia methods on diaphragm contraction in participants undergoing laparotomy.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18 years, - major abdominal surgery cases Exclusion Criteria: - body mass index (BMI) >35 kg/m2 - illiteracy, - communication issues, - neuromuscular disorders, - Advanced chronic respiratory disease, - Previous abdominal or thoracic surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasonography
Using ultrasonography to measure diaphragm thickness

Locations

Country Name City State
Turkey Prof. Dr. Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The impact of laparotomy on diaphragm thickness. Comparison of diaphragm muscle measurements before and after surgery Measurement at the 1st postoperative hour
Secondary The effect of analgesia methods on diaphragm thickness in patients undergoing laparoscopic surgery. Comparison of diaphragm muscle measurements before and after surgery Measurement at the 1st postoperative hour
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