Erector Spinae Plane Block in Renal Transplantation Donors

September 20, 2022 updated by: Özlem Özkalaycı, Koç University Hospital

Effects of Erector Spinae Plane Block on Opioid Consumption in Renal Transplantation Donors

Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively.

The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34010
        • Koç University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Donor patients scheduled for elective nephrectomy in renal transplantation surgery
  • ASA I-II
  • Patients who are aged between 18-75

Exclusion Criteria:

  • Skin infection at the Erector Spina Plan Block area
  • Coagulation disorder or using anticoagulant drugs
  • End-stage organ and system failure
  • Severe pulmonary and/or cardiovascular problems
  • Substance addiction or known psychiatric or mental problems
  • Chronic painkiller usage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector Spinae Plane Block
Erector Spinae Plane Block will be administered to this group.
Procedure: Erector Spinae Plane Block
Erector Spinae Plane Block will be administered before the surgery.
Procedure: Intravenous fentanyl patient control device
24-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
24-hour fentanyl consumption will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl consumption
Time Frame: Postoperative 24 hours
The amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Postoperative 24 hours
Pain of patients will be evaluated and recorded according to the Visual Analog Scale.
Postoperative 24 hours
Modified Aldrete Score
Time Frame: Postoperative 1 hour
Modified Aldrete Score will be used in patient recovery, and scores will be recorded at 5 minute intervals.
Postoperative 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

April 10, 2022

Study Completion (Actual)

April 14, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KocUniversityH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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