Clinical trial NCT04997655: The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness
Official title: The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness in Adult Patients After Laparoscopic Cholecystectomy Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Keywords: Laparoscopic Cholecystectomy Operation
Diaphragm Thickness
Upper Transabdominal Plain Block
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragm Thickness
timeFrame: 5 minutes before general anesthesia
measure: Diaphragm Thickness
timeFrame: 5 minutes after surgery
measure: Diaphragm Thickness
timeFrame: 5 minutes after upper abdominal plane block
Secondary outcomes:
measure: Oxygen saturation
timeFrame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
measure: Visual analogue scale
timeFrame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Yasin Tire
state: Meram
Study officials:
affiliation: Konya City Hospital
name: Yasin Tire
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.