Erector Spinae Plane Block in Liver Transplantation Donors

Sponsor
Medipol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05406388
Collaborator
(none)
50
1
2
20.2
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane Block
  • Procedure: Intravenous fentanyl patient control device
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are two model for this study. The first group is erector spinae plane block group. The second one is control group.There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors
Actual Study Start Date :
Dec 24, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Erector Spinae Plane Block

Erector Spinae Plane Block for Postoperative Analgesia

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

Active Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours]

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

Secondary Outcome Measures

  1. Visual Analog Scale [Change from baseline pain scores at postoperative 0, 2, 4, 6, 112, 24, 36 and 48 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

  • Principal Investigator: Tumay Uludag Yanaral, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tumay Uludag Yanaral, Assistant professor, MD, Medipol University
ClinicalTrials.gov Identifier:
NCT05406388
Other Study ID Numbers:
  • MEDIPOLU-973
First Posted:
Jun 6, 2022
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022