Subcostal TAP Block With Single or Multiple Injection

February 16, 2025 updated by: mesure gul nihan ozden, Istanbul Medeniyet University

The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations

It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Considering that applying technique is important in this block, the results of this study can guide practitioners in this field.

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

A total of 90 patients, aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for laparoscopic cholecystectomy, will be enrolled in this study. Exclusion criteria encompasse a history of allergy to local anesthetics, chronic analgesic use, psychiatric disorders, renal or hepatic dysfunction, coagulopathy, a body mass index (BMI) > 40 kg/m², and pregnancy. Patients in Group S receive a subcostal TAP block with a single injection, patients in Group T receive a subcostal TAP block with multiple injections, and patients in Group C will not receive any form of block.

Standard monitoring protocols will be implemented upon arrival in the operating theatre and heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded during operation. Anesthesia will be induced using propofol (2 mg/kg) and fentanyl (1 μg/kg) and muscle relaxation is achieved with rocuronium (0.5 mg/kg). and maintained using sevoflurane in a 50:50 air/oxygen mixture at a flow rate of 1 L/min. Intraoperative analgesia will be provided through a remifentanil infusion at a rate of 0-0.2 μg/kg/min.

Prior to the initiation of surgery, the subcostal TAP block will be administered in Groups S and T under sterile conditions using ultrasound guidance. A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the left sides of the patients in Group S. The patients in Group T will be given three distinct injections to their left sides: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.

Laparoscopic cholecystectomy will be performed using four trocar placements on the right side of the abdomen. Postoperative analgesia was managed with a patient-controlled analgesia (PCA) device containing tramadol.

Postoperative remifentanil concumption will be estimated at the end of the operation. Assessments will be conducted at 30th minute, 1st, 3rd, 6st and 24th hours postoperatively, with parameters including pain, nausea, and total PCA consumption. Pain intensity will be measured using the Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain). Postoperative nausea and vomiting (PONV) will be evaluated using a verbal descriptive scale (VDS) (0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV) [10]. Patient satisfaction will beevaluated at discharge using a five-point Likert scale (1 = strongly unsatisfied, 5 = strongly satisfied). Complications, including infection, bleeding, and subcutaneous emphysema will be documented.

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.
Interventional

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.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Locations

  • Turkey
      • İ̇stanbul, Turkey, 34730
        • İstanbul Medeniyet University
      • İ̇stanbul, Turkey, 34887
        • Medeniyet University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-65 years old
  2. ASA I-III
  3. Patients scheduled for laparoscopic cholecystectomy operations

Exclusion Criteria:

  1. Those who have previously had neurological and psychiatric disease symptoms and use drugs (TIA, syncope, dementia, depression, bipolar disorder, etc.)
  2. Patients with known allergy to local anesthetics
  3. Chronic opioid or corticosteroid users
  4. Those with coagulopathy
  5. Those with local or systemic infections
  6. BMI>40 kg/m2

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Multiple injection subcostal transversus abdominis plane block
. The patients in multiple injection will be given three distinct injections: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.
Other: Multiple injection subcostal transversus abdominis plane block
Multiple injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 5 ml between transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volume lateral to this point near the subcostal margin.
Active Comparator: Single injection subcostal transversus abdominis plane block
A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the patients in Group S.
Other: Single injection subcostal transversus abdominis plane block
Single injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 20 ml between tranvers and rectus abdominis muscle immediately next to the linea semilunaris.
Active Comparator: Without Block
The patients in this group will not receive any block
Procedure: Without Block
The patients in this group will not receive block

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
Tramadol consumption
Time Frame: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively
Postoperative opiod consumption
10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively
Remifentanil consumption
Time Frame: up to 2 hours
Intraoperative opiod consumption
up to 2 hours

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
Visual analog scale
Time Frame: 30. minute
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
30. minute
Visual analog scale
Time Frame: 1. hour
Visual ananlog scale: 0 = no pain; 10 = the most severe pain you can imagine
1. hour
Visual analog scale
Time Frame: 3. hour
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
3. hour
Visual analog scale
Time Frame: 6. hour
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
6. hour
Visual analog scale
Time Frame: 24. hour
Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine
24. hour
Postoperative nausea and vomiting
Time Frame: 30. minute
Verbal descriptive scale. 0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
30. minute
Postoperative nausea and vomiting
Time Frame: 1. hour
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
1. hour
Postoperative nausea and vomiting
Time Frame: 3. hour
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
3. hour
Postoperative nausea and vomiting
Time Frame: 6. hour
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
6. hour
Postoperative nausea and vomiting
Time Frame: 24. hour
Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV
24. hour
Patient satisfaction
Time Frame: 24. hour
Five-point Likert scale: 1 = strongly unsatisfied, 5 = strongly satisfied
24. hour

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.
Istanbul Medeniyet University

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.
December 1, 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.
May 31, 2023

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.
June 1, 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).
March 26, 2023

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.
April 12, 2023

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.
April 24, 2023

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 25, 2025

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.
February 16, 2025

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.
February 1, 2025

More Information

Terms related to this study

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.
  • IstanbulMU Subcostal TAP Block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings