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Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT04209439
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ultrasound guided erector spinae plane block

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

Drug: 30 ml %0.25 bupivacaine
Ultrasound-guided erector spinae plane block
Active Comparator: Dexketoprofen-trometamol

intravenous 50 mg dexketoprofen-trometamol

Drug: Dexketoprofen-trometamol
50 mg Dexketoprofen-trometamol intravenous

Outcome Measures

Primary Outcome Measures

  1. Number of analgesic consumption [1 hour]

    Fentanyl

Secondary Outcome Measures

  1. Numeric Rating Scale [1 hour]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ali Ahiskalioglu Erzurum Turkey 25100

Sponsors and Collaborators

  • Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Ahiskalioglu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT04209439
Other Study ID Numbers:
  • AUTF ANESTHESIAEMERGENCY
First Posted:
Dec 24, 2019
Last Update Posted:
Jan 29, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colic
Renal Colic
Dexketoprofen trometamol
Bupivacaine

Study Results

No Results Posted as of Jan 29, 2020