Comparison of M-TAPA Block and ESP Block İn Laparoscopic Cholesystektomy (MTAPA and ESP)

October 24, 2024 updated by: Muharrem Baturu, University of Gaziantep

Comparison of the Effectiveness of M TAPA Block and ESP Block in Laparoscopic Cholecystectomy

After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. MTAPA has been defined as a technique that is performed in the supine position and is easier to apply than the other mentioned blocks. In our study, we aimed to investigate the effectiveness of this block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After laparoscopic cholecystectomy, most patients experience moderate to severe pain, especially in the first 24 hours. The cause of the pain is the skin incision, the carbon dioxide insufflation given into the abdomen for laparoscopy, and the visceral peritoneum.

This pain that occurs in the postoperative period negatively affects the patient's early mobilization, wound healing, and patient comfort. While the toxic effects of nonsteroids used for pain control on the liver and kidneys are known, narcotic analgesics have side effects such as nausea, vomiting, and addiction. In recent years, trunk blocks have begun to be used frequently for pain control in abdominal surgery. Although blocks such as erector spina plane (ESP), paravertebral (PVB), and transverses abdominis plane (TAP) are frequently applied, there are differences in terms of their effectiveness and duration. On the other hand, it is important to give the patient a suitable position for the application.

Modified-thoracoabdominal nerve block (M-TAPA), which is applied especially in the supine position and is easier to apply compared to other blocks, has started to be applied as an alternative method.

In our study, we aimed to compare the effectiveness and duration of the MTAPA block compared to other trunk blocks such as ESP.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

  • Turkey
    • Gaziantep
      • Şehitkamil, Gaziantep, Turkey, 27031
        • University of Gaziantep

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: ASAI-III , 18-70 yaş, elective surgery -

Exclusion Criteria: pregnancy, patient with emegency, patients allergic to local anesthetics, patient with coagülopaty, uncooperative, mentally retarded patients

-

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group M
M TAPA applied group
Procedure: M TAPA block
Grup M: The patients who underwent M-TAPA block were placed in the supine position. The right upper quadrant of the abdomen was cleaned with antiseptic solution. For the block procedure, 20-30 ml of 0.25% bupivacaine, 22G 8.5 cm stimuplex needle and 10-14 Hz high frequency USG were prepared for the procedure. The USG probe was determined in the costochondral area at the mid-clavicular line, and the internal and transversus abdominis muscles were determined. The needle was advanced with the in plane technique from cephalad to caudal, passing through the skin, subcutaneous, external and internal oblique muscles, respectively, and then over the transversus abdominis fascia. After the target was confirmed with 2 ml of saline, 0.3 mg / kg bupivacaine (20-30 ml) was administered.
Active Comparator: Group E
ESB applied Group
Procedure: ESP block group

In Group E, patients who were to undergo ESP block were placed in the lateral position with the right side up. The T8-T10 dorsal region was cleaned appropriately with antiseptic solution. For the block procedure, 20-30cc %0.25 bupivacaine, 22G 8.5cm stimuplex needle and 10-14Hz high frequency USG were prepared for the procedure.

The USG probe is first determined in the sagittal direction, the spinous process of the T10 thoracic vertebra is then followed 1-2 cm above the transverse process, with the in plane technique, the skin, subcutaneous tissue and erector spina muscle are passed, the needle is touched to the transverse process and the target is confirmed with 2cc saline, then 20-30 cc (0.5 mg / kg bupivacaine) of local anesthetic is administered and the procedure is terminated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesia
Time Frame: postoperative 24 hours
Numerical pain score below 3
postoperative 24 hours

Collaborators and Investigators

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

Sponsor

University of Gaziantep

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)

August 15, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANST01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Statistical Analysis Plan
    Information comments: The conformity of numerical data to normal distribution will be tested with the ShaphiroWilk test. Student t test will be used to compare variables that comply with normal distribution in 2 groups, and Mann Whitney U test will be used to compare variables that do not distribute normally in 2 groups. Relationships between categorical variables will be tested with the Chi-square test. Relationships between numerical variables will be tested with the correlation coefficient. SPSS 22.0 package program will be used in the analyses. A P value of less than 0.05 will be considered statistically significant.

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.

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