The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness

NCT04997655 | Completed DMC

• 1 other identifier: KonyaCityH
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General

Keywords

Laparoscopic Cholecystectomy Operation; Diaphragm Thickness; Upper Transabdominal Plain Block

Outcome Measures

Primary Outcomes (3)

• Diaphragm Thickness

  The measurement of Diaphragm Thickness by USG

  5 minutes before general anesthesia

• Diaphragm Thickness

  The measurement of Diaphragm Thickness by USG

  5 minutes after surgery

• Diaphragm Thickness

  The measurement of Diaphragm Thickness by USG

  5 minutes after upper abdominal plane block

Secondary Outcomes (2)

• Oxygen saturation

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

• Visual analogue scale

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

Study Arms (2)

Upper Transabdominal Plain Block

All patients in this group are routinely administered general anesthesia. After extubation, the subcostal transverse abdominis area block was directed laterally along the rectus abdominis muscle by finding the linea alba under the xiphoid region under ultrasound guidance with a 22G echogenic block needle, and 20 ml (8 ml 0.5% bupivacaine, 7 ml prilocaine) into the fascia between the rectus abdominis and transverse abdominis muscles. , 5 ml of saline) drug mixture will be performed by the anesthesiologist in charge of that day, who is not aware of the observational measurement to be made, if there is an indication, as a blind practitioner.

Diagnostic Test: Ultrasound measurement

Opioid analgesia

All patients in this group are routinely administered general anesthesia. Apart from this, in the other group, which does not have peripheral nerve block and only routine opioid analgesia is considered sufficient, only routine peroperative USG diaphragm measurements will be recorded observationally.

Diagnostic Test: Ultrasound measurement

Interventions

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.

Opioid analgesia; Upper Transabdominal Plain Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Patients between the ages of 18-60, of both sexes, who will undergo laparoscopic cholecystectomy, which are evaluated as ASA 1 and ASA 2 anesthesia risk, will be examined.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

With the calculated sample size values, we will need to include at least 68 patients in our study at 0.5 sensitivity and 0.95 power.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30910636 BACKGROUND

• 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.

  PMID: 24365607 RESULT

• 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.

  PMID: 31876624 RESULT

Related Links

• Gülleroğlu, Aykan, et al. "Laparoskopik kolesistektomi operasyonlarında karın içi basınç artışının solunum mekaniği, hemodinami ve metabolizma üzerindeki etkileri." Ok Meydanı Eğitim ve Araştırma Hastanesi Anesteziyoloji ve Reanimasyon Kli
• Andıç, K. D., N. Göğüş, and Ayşe Lafcı. "Laparoskopik Kolesistektomi Geçiren Hastalarda Ultrasonografi Eşliğinde Uygulanan Transversus Abdominis Plan Bloğun Perioperatif Analjezi ve Hasta Konforuna Katkısı." (2021).

Study Officials

• Yasin Tire

  Konya City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Yasin Tire

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 9, 2021
• Study Start: June 2, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 18, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)