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Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

Primary Purpose

Renal Colic

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
30 ml %0.25 bupivacaine
Dexketoprofen-trometamol
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-II patients

Exclusion Criteria:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications

Sites / Locations

  • Ali Ahiskalioglu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrasound guided erector spinae plane block

Dexketoprofen-trometamol

Arm Description

30 ml %0.25 ultrasound-guided erector spinae plane block at the level of T8

intravenous 50 mg dexketoprofen-trometamol

Outcomes

Primary Outcome Measures

Number of analgesic consumption
Fentanyl

Secondary Outcome Measures

Numeric Rating Scale
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. NRS score will be recorded after intervention at 5.,10.,15.,30.,45. and 60. minute

Full Information

First Posted
December 20, 2019
Last Updated
January 28, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04209439
Brief Title
Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain
Official Title
Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves. The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided erector spinae plane block
Arm Type
Active Comparator
Arm Description
30 ml %0.25 ultrasound-guided erector spinae plane block at the level of T8
Arm Title
Dexketoprofen-trometamol
Arm Type
Active Comparator
Arm Description
intravenous 50 mg dexketoprofen-trometamol
Intervention Type
Drug
Intervention Name(s)
30 ml %0.25 bupivacaine
Intervention Description
Ultrasound-guided erector spinae plane block
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen-trometamol
Intervention Description
50 mg Dexketoprofen-trometamol intravenous
Primary Outcome Measure Information:
Title
Number of analgesic consumption
Description
Fentanyl
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Numeric Rating Scale
Description
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. NRS score will be recorded after intervention at 5.,10.,15.,30.,45. and 60. minute
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications
Facility Information:
Facility Name
Ali Ahiskalioglu
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30595427
Citation
Aydin ME, Ahiskalioglu A, Tekin E, Ozkaya F, Ahiskalioglu EO, Bayramoglu A. Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. Am J Emerg Med. 2019 Apr;37(4):794.e1-794.e3. doi: 10.1016/j.ajem.2018.12.042. Epub 2018 Dec 23.
Results Reference
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PubMed Identifier
31496381
Citation
Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.
Results Reference
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PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
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Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

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