The Impact of Laparotomy and Analgesia Methods on Diaphragm

May 7, 2024 updated by: Fethi Gultop, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

The Impact of Laparotomy and Analgesia Methods on Postoperative Diaphragm Muscle Contraction in Major Abdominal Surgeries.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Prof. Dr. Cemil Taşcıoğlu City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for major abdominal surgery due to gastrointestinal tumor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diaphragm contraction fraction
Diaphragm muscle contraction fraction measured before and after surgery
Diagnostic test: ultrasonography
Using ultrasonography to measure diaphragm thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of laparotomy on diaphragm thickness.
Time Frame: Measurement at the 1st postoperative hour
Comparison of diaphragm muscle measurements before and after surgery
Measurement at the 1st postoperative hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02fg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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