The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997655
• Other study ID #: KonyaCityH
• Status: Completed
• Start date: June 2, 2022
• Est. completion date: March 18, 2023

Study information

• Verified date: March 2023
• Source: Konya City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 18, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Diagnostic Test:
• Ultrasound measurement
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.

Locations

Country	Name	City	State
Turkey	Yasin Tire	Konya	Meram

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23. — View Citation

Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682. — View Citation

Vivier E, Muller M, Putegnat JB, Steyer J, Barrau S, Boissier F, Bourdin G, Mekontso-Dessap A, Levrat A, Pommier C, Thille AW. Inability of Diaphragm Ultrasound to Predict Extubation Failure: A Multicenter Study. Chest. 2019 Jun;155(6):1131-1139. doi: 10.1016/j.chest.2019.03.004. Epub 2019 Mar 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm Thickness	The measurement of Diaphragm Thickness by USG	5 minutes before general anesthesia
Primary	Diaphragm Thickness	The measurement of Diaphragm Thickness by USG	5 minutes after surgery
Primary	Diaphragm Thickness	The measurement of Diaphragm Thickness by USG	5 minutes after upper abdominal plane block
Secondary	Oxygen saturation	Oxygen saturation separately for each primary outcome stage	Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
Secondary	Visual analogue scale	The patient's pain will be asked in a scale from 1 to 10.	Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.

External Links

•   Andiç, K. D., N. Gögüs, and Ayse Lafci. "Laparoskopik Kolesistektomi Geçiren Hastalarda Ultrasonografi Esliginde Uygulanan Transversus Abdominis Plan Blogun Perioperatif Analjezi ve Hasta Konforuna Katkisi." (2021).
•   Gülleroglu, Aykan, et al. "Laparoskopik kolesistektomi operasyonlarinda karin içi basinç artisinin solunum mekanigi, hemodinami ve metabolizma üzerindeki etkileri." Ok Meydani Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Kli