Erector Spinae Plane Block in Liver Transplantation Donors

NCT ID: NCT05406388

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-24

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.

Study Groups

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Erector Spinae Plane Block

Erector Spinae Plane Block for Postoperative Analgesia

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Intravenous fentanyl patient control device

Intervention Type PROCEDURE

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

Interventions

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Erector Spinae Plane Block

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

Intervention Type PROCEDURE

Intravenous fentanyl patient control device

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Tumay Uludag Yanaral

Assistant professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tumay Uludag Yanaral

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30477577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17394151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30292068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28188611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29883965 (View on PubMed)

Other Identifiers

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MEDIPOLU-973

Identifier Type: -

Identifier Source: org_study_id

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