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Erector Spinae Plane Block in Liver Transplantation Donors

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Intravenous fentanyl patient control device
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector Spinae Plane Block

Control group

Arm Description

Erector Spinae Plane Block for Postoperative Analgesia

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2022
Last Updated
August 3, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05406388
Brief Title
Erector Spinae Plane Block in Liver Transplantation Donors
Official Title
Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block for Postoperative Analgesia
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No regional anesthesia technique will be applied to the control group.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Intervention Type
Procedure
Intervention Name(s)
Intravenous fentanyl patient control device
Intervention Description
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
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 Outcome Measure Information:
Title
Visual Analog Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tumay Uludag Yanaral
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30477577
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.
Results Reference
background
PubMed Identifier
17394151
Citation
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.
Results Reference
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PubMed Identifier
30292068
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.
Results Reference
background
PubMed Identifier
28188611
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.
Results Reference
background
PubMed Identifier
29883965
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.
Results Reference
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Erector Spinae Plane Block in Liver Transplantation Donors

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