NCT07067996

Brief Summary

this study aims to compare between efficacy of erector spinae plane block and conventional multimodal analgesia in Extracorporeal shock wave lithotripsy

Trial Health

57
Monitor

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 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 13, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 6, 2025

Last Update Submit

July 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • This study aims to evaluate the efficacy of Erector Spinae Plane Block analgesia for patients undergoing ESWL &compare between it and conventional multimodal Analgesia .

    postoperative pain by visual analog score from 0 to 10 (where 0 indicates no pain and 10 the worst possible pain

    6 hours postopertive

Study Arms (2)

group A : will receive Erector Spinae Plane Block in the prone position after URS.

ACTIVE COMPARATOR

* Patients in the block group (Group A)will receive the ESPB in the prone position after URS. ESPB needle insertion sites will be tolerated to the location of the stone, between T7-T10 vertebra levels. With these adjustments, Following the marking of the thoracic vertebrae levels with a marker pen, * The intervention will be initiated when the transverse processes and costotransverse joints on the relevant level will be distinguished using a high frequency(10-15 MHZ) linear ultrasound probe. The needle will be inserted at a 30° angle to the skin in an in-plane and craniocaudal fashion * Proper placement will be confirmed with ultrasonography and then 20 mL of 0.25% bupivacaine solution\&5 ml lidocaine 1% will be administered through the needle for intraoperative and postoperative anaglesia.

Procedure: erector spinae plane block

group B : will receive nalbuphine

ACTIVE COMPARATOR

•(Group B) patients will receive opioids ,nalbuphine( ,1 )mg/kg over 10 minutes then repeat the dose if needed \&monitoring patients for respiratory depression

Drug: Nalbuphine

Interventions

erector spinae plane block will be given as intraoperive analgesia for patients undergoing Extracorporeal shock wave lithotripsy

group A : will receive Erector Spinae Plane Block in the prone position after URS.

Nalbuphine will be given as intraopertive analgesia for patients undergoing Extracorporeal shock wave lithotripsy

group B : will receive nalbuphine

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult Patients undergoing ESWL with 2-3 cm renal stones
  • patients between the ages of 21 and 60,
  • both sexes,
  • BMI ≥18≤30 kg/m²
  • Able to give informed consent.
  • Patients older than 18 years with American Society of Anesthesiologists Physical Status I or II and

You may not qualify if:

  • Coagulopathy or on anticoagulants
  • Infection at the ESPB injection site
  • BMI ≥30 kg/m²
  • Patient refusal.
  • patients with advanced respiratory, renal, hepatic, neurological, or psychiatric disease, pregnant or nursing women.
  • patients with a history of allergies to any study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Karaaslan M, Olcucuoglu E, Kurtbeyoglu S, Tonyali S, Yilmaz M, Odabas O. Erector spinae plane block prior to extracorporeal shock wave lithotripsy decreases fluoroscopy time and promise a comfortable procedure for renal stones: A prospective randomized study. Actas Urol Esp (Engl Ed). 2023 Nov;47(9):566-572. doi: 10.1016/j.acuroe.2023.04.001. Epub 2023 Apr 20. English, Spanish.

  • Yayik AM, Ahiskalioglu A, Erguney OD, Oral Ahiskalioglu E, Alici H, Demirdogen SO, Adanur S. Analgesic efficacy of ultrasound-guided quadratus lumborum block during extracorporeal shock wave lithotripsy. Agri. 2020 Jan;32(1):44-47. doi: 10.5505/agri.2017.54036.

  • Alhashemi JA, Kaki AM. Dexmedetomidine in combination with morphine PCA provides superior analgesia for shockwave lithotripsy. Can J Anaesth. 2004 Apr;51(4):342-7. doi: 10.1007/BF03018237.

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Amr A Abdelaziz, resident

CONTACT

Khaled M Hassan, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Anesthesia,Sugical Icu,Pain management Faculty of Medicine Sohag Univesity

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 16, 2025

Study Start

June 13, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations