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CompletedNCT06300372Updated Jan 20, 2025

Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors

An interventional study of M-TAPA plane block and Postoperative pain management in Liver Failure and Acute Postoperative Pain, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Liver Failure
  • Acute Postoperative Pain

Keywords

  • Modified Thoracoabdominal Nerve Plane Block
  • Liver Transplantation
  • Acute Postoperative Pain
03

In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's enrollment of 50 is above the median of 43 across 276 interventional studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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 · Procedure: Postoperative pain management

  • 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

Interventions

  • ProcedureM-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).

  • ProcedurePostoperative 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.

06

What researchers measure

Primary outcomes

  1. Opioid consumption (Fentanyl PCA)

    The primary aim is to compare postoperative opioid consumption from the PCA device.

    Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours

Secondary outcomes

  1. Pain scores (Numerical rating scale-NRS

    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.

    Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]

  2. Need for rescue analgesia (meperidine)

    The secondary aim is to compare rescue analgesia used in the postoperative 48 h.

    Time frame: Postoperative 48 hours period

  3. Adverse events

    The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.

    Time frame: Postoperative 48 hours period

07

Study locations

1 site
  • Istanbul Medipol University Mega Hospital Complex
    Istanbul, Bagcilar, Turkey
08

References and documents

Publications

  • Yong BH, Tsui SL, Leung CC, Lo CM, Liu CL, Fan ST, Young K. Management of postoperative analgesia in living liver donors. Transplant Proc. 2000 Nov;32(7):2110. doi: 10.1016/s0041-1345(00)01592-x. No abstract available. PubMed 11120091 ↗
  • Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available. PubMed 29883965 ↗
  • Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702. PubMed 20830871 ↗
  • Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available. PubMed 30388604 ↗
  • Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available. PubMed 30639940 ↗
  • Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available. PubMed 31212124 ↗

Individual participant data

Plan to share: No — The investigators will not share individual patient data(IPD)

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06300372
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Ayse Ince (Assistant Professor, Istanbul Medipol University Hospital) — Principal investigator
First posted
Mar 8, 2024
Start date
Apr 1, 2024
Primary completion
Jan 10, 2025
Completion
Jan 10, 2025
Last update
Jan 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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