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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04863716
Other study ID # KocUniversityH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2021
Est. completion date April 14, 2022

Study information

Verified date September 2022
Source Koc University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 14, 2022
Est. primary completion date April 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Procedure:
Erector Spinae Plane Block
Erector Spinae Plane Block will be administered before the surgery.
Intravenous fentanyl patient control device
24-hour fentanyl consumption will be recorded.

Locations

Country Name City State
Turkey Koç University Hospital Istanbul Zeytinburnu

Sponsors (1)

Lead Sponsor Collaborator
Koc University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fentanyl consumption 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 Visual Analog Scale Pain of patients will be evaluated and recorded according to the Visual Analog Scale. Postoperative 24 hours
Secondary Modified Aldrete Score Modified Aldrete Score will be used in patient recovery, and scores will be recorded at 5 minute intervals. Postoperative 1 hour
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