Erector Spinae Plane Block in Liver Transplantation Donors

NCT05406388 | Completed

• 1 other identifier: MEDIPOLU-973
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

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.

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

Secondary Outcomes (1)

• Visual Analog Scale

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

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Erector Spinae Plane Block for Postoperative Analgesia

Procedure: Erector Spinae Plane Block

Control group

ACTIVE COMPARATOR

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

Procedure: Intravenous fentanyl patient control device

Interventions

Erector Spinae Plane Block PROCEDURE

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

Erector Spinae Plane Block

Intravenous fentanyl patient control device PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, 34070, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30477577 BACKGROUND

• 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.

  PMID: 17394151 BACKGROUND

• 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.

  PMID: 30292068 BACKGROUND

• 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.

  PMID: 28188611 BACKGROUND

• 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.

  PMID: 29883965 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Tumay Uludag Yanaral

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, MD

Model Details: There are two model for this study. The first group is erector spinae plane block group. The second one is control group.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: December 24, 2020
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)