The Impact of Laparotomy and Analgesia Methods on Diaphragm

Recruiting

• Conditions: Colorectal Neoplasms; Gastrectomy
• Interventions: Diagnostic Test: ultrasonography

• Registration Number: NCT06403540
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-08
• Study Start: 2025-01-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-07
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diaphragm contraction fraction	ultrasonography	Diaphragm muscle contraction fraction measured before and after surgery

Primary Outcome Measures

Name	Time	Method
The impact of laparotomy on diaphragm thickness.	Measurement at the 1st postoperative hour	Comparison of diaphragm muscle measurements before and after surgery

Secondary Outcome Measures

Name	Time	Method
The effect of analgesia methods on diaphragm thickness in patients undergoing laparoscopic surgery.	Measurement at the 1st postoperative hour	Comparison of diaphragm muscle measurements before and after surgery

Trial Locations

Locations (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital; 🇹🇷 Istanbul, Turkey