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The Impact of Laparotomy and Analgesia Methods on Diaphragm

NCT06403540 — Terminated, 66 participants, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

RegistryNCT06403540
StatusTerminated - The study was terminated prematurely because the planned sample size could not be achieved due to insufficient participant recruitment.
Study typeObservational
Enrollment66 (Actual)
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
ConditionsColorectal Neoplasms, Gastrectomy
Interventionsultrasonography (Diagnostic test)
Datesstart 2025-01-30, primary completion 2025-08-15, completion 2025-09-01, first posted 2024-05-08, last updated 2026-10-22
Locations1 site in Turkey (Türkiye)

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
diaphragm contraction fractionDiagnostic Test: ultrasonographyDiaphragm muscle contraction fraction measured before and after surgery
  • ultrasonography (Diagnostic test): Using ultrasonography to measure diaphragm thickness

+Outcome measures

Primary outcomes

  • The impact of laparotomy on diaphragm thickness. [Measurement at the 1st postoperative hour]: Comparison of diaphragm muscle measurements before and after surgery

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Prof. Dr. Cemil Taşcıoğlu City HospitalIstanbulTurkey (Türkiye)

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