The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness

March 19, 2023 updated by: Yasin Tire, MD, Konya City Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Meram
      • Konya, Meram, Turkey, 42140
        • Yasin Tire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diaphragm Thickness
Time Frame: 5 minutes before general anesthesia
The measurement of Diaphragm Thickness by USG
5 minutes before general anesthesia
Diaphragm Thickness
Time Frame: 5 minutes after surgery
The measurement of Diaphragm Thickness by USG
5 minutes after surgery
Diaphragm Thickness
Time Frame: 5 minutes after upper abdominal plane block
The measurement of Diaphragm Thickness by USG
5 minutes after upper abdominal plane block

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
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.
Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konya City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yasin Tire, Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KonyaCityH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I plan to make individual participant data (IPD) available to only responsible researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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