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Completed

NCT Number: NCT04997655

The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness

In the study, patients of both sexes between the ages of 18 and 60 who will undergo laparoscopic cholecystectomy will be examined. In this patient group, the change in the inspiratory and expiratory diaphragmatic thickness before and after laparoscopic cholecystectomy operation in the upper transabdominal block group will be examined.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

About this study

The use of ultrasonography (USG) in operating rooms is increasing day by day. Diaphragm thickness can be evaluated by ultrasonography and is used as a bedside method studies have proven that the evaluation of diaphragmatic thickness contributes to the observation of diaphragmatic function and the evaluation of respiratory workload. Measurement of diaphragmatic thickness is a method used in operating rooms and intensive care units to make the decision to wean from mechanical ventilation and extubation. Laparoscopic gallbladder operations are a very common operation in the adult age group in the operating room. In these cases who were intubated and extubated at the end of the operation, regression in respiratory function is observed, especially due to right upper quadrant pain appropriate to the location of the liver. For this reason, the respiratory functions of patients who will have gallbladder surgery will be routinely evaluated before and after gallbladder surgery in our clinic with the help of USG and routinely apply analgesic methods, including peripheral nerve blocks, to patients with pain.

In this study, it will be planned to observe the effect of upper transabdominal area block, which is routinely performed post-operatively in laparoscopic gallbladder operations, on diaphragmatic thickness and therefore on respiratory capacity, and observationally evaluating diaphragmatic thickness measurements by USG, which is routinely performed post-operatively and the measurement records are noted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 18-60
  • Both sexes
  • Patiets are evaluated as ASA 1 and ASA 2 anesthesia risk, will be examined.

Exclusion criteria

  • Under 18 years old, over 60 years old
  • BMI>35 kg/m2
  • Bleeding diathesis
  • Local anesthetic allergy
  • Infection in the area of TAP (Trans abdominal plane) block application
  • Illiteracy, communication problem
  • Previous upper abdomen operation
  • Transition to open surgery Cases
  • Severe chronic respiratory disease
  • Neuromuscular disorders.

Treatment and study plan

Ultrasound measurement

Diagnostic Test

In the patient group who will undergo elective laparoscopic cholecystectomy, the diaphragmatic thickness values measured and recorded routinely at the pre-operative, post-extubation and post-operative 30th minute, at the end of inspiration and expiration, and the inspiratory amplitude in m-mode in the ultrasound measured from the right anterior axillary line subcostal area were observed as observational data. will be saved in our file.

Primary outcomes

  1. Diaphragm Thickness

    Time frame: 5 minutes before general anesthesia

    The measurement of Diaphragm Thickness by USG

  2. Diaphragm Thickness

    Time frame: 5 minutes after surgery

    The measurement of Diaphragm Thickness by USG

  3. Diaphragm Thickness

    Time frame: 5 minutes after upper abdominal plane block

    The measurement of Diaphragm Thickness by USG

Secondary outcomes

  1. Oxygen saturation

    Time frame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.

    Oxygen saturation separately for each primary outcome stage

  2. Visual analogue scale

    Time frame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.

    The patient's pain will be asked in a scale from 1 to 10.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness in Adult Patients After Laparoscopic Cholecystectomy Operation

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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