NCT04213924

Brief Summary

Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

December 27, 2019

Last Update Submit

June 3, 2020

Conditions

Keywords

Extracorporeal Shockwave LithotripsyErector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    Opioid consumption during procedure

    Intraoperative 30 minutes

Secondary Outcomes (1)

  • Visual Analog Pain Score

    Intraoperative 30 minutes

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

Ultrasound-guided erector spinae plane block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine

Drug: Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml

Group NSAII

ACTIVE COMPARATOR

lidocaine 5% gel and 800 mg ibuprofen intravenously

Drug: 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously

Interventions

Erector spinae plane block, 30 min before the ESWL procedure.

Group ESPB

5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure.

Group NSAII

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 undergoing Extracorporeal Shockwave Lithotripsy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • 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
  • Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. No abstract available.

    PMID: 29414615BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 27, 2019

First Posted

December 30, 2019

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations