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CompletedNCT05406388Updated Aug 7, 2023

Erector Spinae Plane Block in Liver Transplantation Donors

An interventional study of Erector Spinae Plane Block and Intravenous fentanyl patient control device in Pain, Postoperative, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-07.

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

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Dec 2020, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.

Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.

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Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 41 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Donor patients scheduled for elective hepatectomy in liver transplantation surgery
  • ASA I-II
  • Patients who are aged between 18-65

Exclusion criteria

Exclusion Criteria:

  • Patients who do not accept the procedure
  • Skin infection at the site of Erector Spina Plan Block area
  • Coagulation disorder or using anticoagulant drugs
  • Known local anesthetics and opioid allergy
  • Severe pulmonary and/or cardiovascular problems
  • Substance addiction or known psychiatric or mental problems
  • Chronic painkiller usage
  • Pregnancy or lactation
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Study design

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

Study arms

  • Active comparator
    Erector Spinae Plane Block

    Erector Spinae Plane Block for Postoperative Analgesia

    Procedure: Erector Spinae Plane Block

  • Active comparator
    Control group

    No regional anesthesia technique will be applied to the control group.

    Procedure: Intravenous fentanyl patient control device

Interventions

  • ProcedureErector Spinae Plane Block

    Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.

  • ProcedureIntravenous fentanyl patient control device

    Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.

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What researchers measure

Primary outcomes

  1. Opioid consumption

    The amount of fentanyl required by the patient and given by the device will be recorded for the first 48 hours.

    Time frame: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours

Secondary outcomes

  1. Visual Analog Scale

    Pain of patients will be evaluated and recorded according to the Visual Analog Scale.

    Time frame: Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours

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Study locations

1 site
  • Istanbul Medipol University Hospital
    Istanbul, 34070, Turkey
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References and documents

Publications

  • Dewe G, Steyaert A, De Kock M, Lois F, Reding R, Forget P. Pain management in living related adult donor hepatectomy: feasibility of an evidence-based protocol in 100 consecutive donors. BMC Res Notes. 2018 Nov 26;11(1):834. doi: 10.1186/s13104-018-3941-1. PubMed 30477577 ↗
  • Chhibber A, Dziak J, Kolano J, Norton JR, Lustik S. Anesthesia care for adult live donor hepatectomy: our experiences with 100 cases. Liver Transpl. 2007 Apr;13(4):537-42. doi: 10.1002/lt.21074. PubMed 17394151 ↗
  • Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. PubMed 30292068 ↗
  • El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available. PubMed 28188611 ↗
  • 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05406388
Lead sponsor
Medipol University
Responsible party
Tumay Uludag Yanaral (Assistant professor, MD, Medipol University) — Principal investigator
First posted
Jun 6, 2022
Start date
Dec 24, 2020
Primary completion
May 1, 2023
Completion
Aug 1, 2023
Last update
Aug 7, 2023

Study contacts

Tumay Uludag Yanaral
principal investigator · Medipol University

Oversight

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

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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