NCT05937256

Brief Summary

This study is designed to compare analgesic effect of both the ultrasound (US)-guided QLB and ESPB blocks during ESWL and their effect on stone fragmentation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2023

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

First Submitted

Initial submission to the registry

May 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

May 28, 2023

Last Update Submit

March 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analgesic Effect: cumulative opioid dose

    Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes)

    At 30 minutes

Secondary Outcomes (7)

  • Stone fragmentation: clearance rate

    one week after ESWL session

  • Stone fragmentation: shockwave energy

    at 30 minutes

  • Block failure rate

    Immediately After 20 minutes of intervention

  • The regional block time

    procedure (At the end of intervention)

  • Feasibility of visualisation

    procedure (At the end of intervention)

  • +2 more secondary outcomes

Study Arms (3)

Group Q

ACTIVE COMPARATOR

(n=30) will receive unilateral quadratus lumborum block type III

Procedure: Quadratus lumborum block type III

Group E

ACTIVE COMPARATOR

(n=30) will receive unilateral erector spinae plane block

Procedure: Erector spinae plane block

Group C

NO INTERVENTION

(n=30) will be control group receiving no intervention, managed only with conventional analgesia

Interventions

Patients will be placed in lateral decubitus position with the side of the target stone facing up. After sterilization and draping of the skin, using US probe the block will be applied targeting the fascial plane between the quadratus lumborum and psoas major muscles (anterior aspect of the quadratus lumborum). After 20 min, sensory blockade will be evaluated with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients will be transferred to ESWL Room.

Group Q

Patients will be placed in the lateral decubitus position according to the selected site. After sterilization and draping of the skin, using US probe, the block will be applied in the plane deep to the erector spinae muscles and superficial to the transverse process. After 20 min, sensory blockade will be assessed with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients is transferred to ESWL Room.

Group E

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed written consent obtained
  • Age 18-60
  • Both sex
  • American Society of Anesthesiologists(ASA) physical status: I, II
  • Stone pelvis less than 2.5 cm
  • Indicated for ESWL

You may not qualify if:

  • refusal of participation by parents or caregivers.
  • ASA physical status: \> II
  • Stone pelvis \>2.5 cm
  • Chronic pain
  • On chronic NSAID or opioid
  • Substance addict
  • Known local anesthetic drug sensitivity.
  • Preexisting infection at block site
  • Coagulopathy or anticoagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (5)

  • 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
  • Bovelander E, Weltings S, Rad M, van Kampen P, Pelger RCM, Roshani H. The Influence of Pain on the Outcome of Extracorporeal Shockwave Lithotripsy. Curr Urol. 2019 Mar 8;12(2):81-87. doi: 10.1159/000489424.

    PMID: 31114465BACKGROUND
  • Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.

    PMID: 35030493BACKGROUND
  • El-Boghdadly K, Desai N, Halpern S, Blake L, Odor PM, Bampoe S, Carvalho B, Sultan P. Quadratus lumborum block vs. transversus abdominis plane block for caesarean delivery: a systematic review and network meta-analysis. Anaesthesia. 2021 Mar;76(3):393-403. doi: 10.1111/anae.15160. Epub 2020 Jul 4.

    PMID: 32621529BACKGROUND

MeSH Terms

Conditions

PainLithiasis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Mohamed G Ahmed, MD

    Lecturer in anesthesiology intensive care and pain management, South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: controlled, randomized, assessor blinded clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in anesthesiology, intensive care and pain management

Study Record Dates

First Submitted

May 28, 2023

First Posted

July 10, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations