NCT04209439

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

December 20, 2019

Last Update Submit

January 28, 2020

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

  • Number of analgesic consumption

    Fentanyl

    1 hour

Secondary Outcomes (1)

  • Numeric Rating Scale

    1 hour

Study Arms (2)

ultrasound guided erector spinae plane block

ACTIVE COMPARATOR

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

Drug: 30 ml %0.25 bupivacaine

Dexketoprofen-trometamol

ACTIVE COMPARATOR

intravenous 50 mg dexketoprofen-trometamol

Drug: Dexketoprofen-trometamol

Interventions

30 ml %0.25 bupivacaineDRUG

Ultrasound-guided erector spinae plane block

ultrasound guided erector spinae plane block
Dexketoprofen-trometamolDRUG

50 mg Dexketoprofen-trometamol intravenous

Dexketoprofen-trometamol

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Ahiskalioglu

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 30595427BACKGROUND

  • 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.

    PMID: 31496381BACKGROUND

  • 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.

    PMID: 27501016BACKGROUND

MeSH Terms

Conditions

Renal Colic

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 28, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)