Erector Spinae Plane Block in Renal Transplantation Donors

Sponsor

Koc University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04863716

Collaborator

(none)

Enrollment

Location

Arms

13.6

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 23, 2021

Actual Primary Completion Date :

Apr 10, 2022

Actual Study Completion Date :

Apr 14, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Fentanyl consumption [Postoperative 24 hours]
The amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Koç University Hospital	Istanbul	Zeytinburnu	Turkey	34010

Sponsors and Collaborators

Koc University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Özlem Özkalaycı, Anesthesiologist, Koc University Hospital

ClinicalTrials.gov Identifier:

NCT04863716

Other Study ID Numbers:

KocUniversityH

First Posted:

Apr 28, 2021

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Özlem Özkalaycı, Anesthesiologist, Koc University Hospital

Laparoscopic Nephrectomy

Erector Spinae Plane Block

Additional relevant MeSH terms:

Fentanyl

Study Results

No Results Posted as of Aug 17, 2022