- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863716
Erector Spinae Plane Block in Renal Transplantation Donors
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34010
- Koc University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Erector Spinae Plane Block will be administered before the surgery.
24-hour fentanyl consumption will be recorded.
|
Active Comparator: Control Group
No regional anesthesia technique will be applied to the control group.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KocUniversityH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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