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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05406388
Other study ID # MEDIPOLU-973
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 24, 2020
Est. completion date August 1, 2023

Study information

Verified date August 2023
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Donor patients scheduled for elective hepatectomy in liver transplantation surgery - ASA I-II - Patients who are aged between 18-65 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spinae Plane Block
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Intravenous fentanyl patient control device
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.

Locations

Country Name City State
Turkey Istanbul Medipol University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Visual Analog Scale Pain of patients will be evaluated and recorded according to the Visual Analog Scale. Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
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