NCT04863716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

April 20, 2021

Last Update Submit

September 20, 2022

Conditions

Keywords

Laparoscopic NephrectomyErector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Visual Analog Scale

    Postoperative 24 hours

  • Modified Aldrete Score

    Postoperative 1 hour

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Erector Spinae Plane Block will be administered to this group.

Procedure: Erector Spinae Plane BlockProcedure: Intravenous fentanyl patient control device

Control Group

ACTIVE COMPARATOR

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

Procedure: Intravenous fentanyl patient control device

Interventions

Erector Spinae Plane Block will be administered before the surgery.

Erector Spinae Plane Block

24-hour fentanyl consumption will be recorded.

Control GroupErector Spinae Plane Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 28, 2021

Study Start

April 28, 2021

Primary Completion

April 10, 2022

Study Completion

April 14, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations