Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors

January 17, 2025 updated by: Ayse Ince, Istanbul Medipol University Hospital

Ultrasonography-Guided Bilateral Modified Thoracoabdominal Nerve Plane Block With Perichondrial Approach (M-TAPA) For Postoperative Pain Management In Living Liver Donors: Randomized Controlled Study.

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open hepatic resection for living liver transplantation donor surgery can cause severe postoperative pain and if not treated properly, may increase the risk of chronic pain development, which has a significant impact on the patient's daily life quality. The use of interfascial plane blocks for pain control has increased in recent years, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Additionally, reducing postoperative opioid consumption may be a useful strategy to provide hemodynamic stability and promote early mobilization. Case reports state interfascial plane blocks to be effective and safe for providing effective analgesia compared to systemic analgesia in living liver donor surgeries. As studies are showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that the M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

50

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
    • Bagcilar
      • Istanbul, Bagcilar, Turkey
        • Istanbul Medipol University Mega Hospital Complex

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

No

Description

Inclusion Criteria: Patients American Society of Anesthesiologists (ASA) classification I- II Scheduled for living liver donation surgery for liver transplantation under general anesthesia

Exclusion Criteria: Patients

  • with history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • with allergies or sensitivity to drugs used,
  • with an infection on the puncture site
  • who do not accept the procedure or participate in the study

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
Intervention / Treatment
Experimental: Group A=M-TAPA block group
M-TAPA plane block will be performed and standard postoperative pain management protocols will be applied.
Procedure: M-TAPA plane block
As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Pajunk Sonoplex Nanoline Stim Cannula, Germany) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied bilaterally (60 ml in total).
Procedure: Postoperative pain management
For preemptive analgesia, morphine (Morfin ®) 0.05mg/kg and Ibuprofen 400mg IV (Ibuprofen®) will be administered to all patients before the surgical incision. An additional dose of ibuprofen 400mg IV, meperidine (Aldolan ®), and tramadol (Contramal®) 1mg/kg IV will be administered to all patients 30 minutes before wound closure.10 mcg/ml fentanyl containing PCA will be connected to all patients without infusion and boluses 0,35 mcg/kg,15-minute lockout period, maximum 100 mcg per hour. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®)will be administered as a rescue analgesic.
Active Comparator: Group B = control group
Only standard postoperative pain management protocols will be applied. No plane blocks will be applied
Procedure: Postoperative pain management
For preemptive analgesia, morphine (Morfin ®) 0.05mg/kg and Ibuprofen 400mg IV (Ibuprofen®) will be administered to all patients before the surgical incision. An additional dose of ibuprofen 400mg IV, meperidine (Aldolan ®), and tramadol (Contramal®) 1mg/kg IV will be administered to all patients 30 minutes before wound closure.10 mcg/ml fentanyl containing PCA will be connected to all patients without infusion and boluses 0,35 mcg/kg,15-minute lockout period, maximum 100 mcg per hour. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®)will be administered as a rescue analgesic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption (Fentanyl PCA)
Time Frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
The primary aim is to compare postoperative opioid consumption from the PCA device.
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores (Numerical rating scale-NRS
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]
The secondary aim is to compare NRS at the postoperative 48 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded.
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]
Need for rescue analgesia (meperidine)
Time Frame: Postoperative 48 hours period
The secondary aim is to compare rescue analgesia used in the postoperative 48 h.
Postoperative 48 hours period
Adverse events
Time Frame: Postoperative 48 hours period
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Postoperative 48 hours period

Collaborators and Investigators

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

Sponsor

Istanbul Medipol University 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

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)

April 1, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

March 3, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol Hospital 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not share individual patient data(IPD)

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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