Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

NCT07177625 | Not Yet Recruiting

• 1 other identifier: FSCH-SBÜ-2025/09
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, observational study is to evaluate the effect of retrolaminar block (RLB) on patient comfort and analgesic effectiveness during extracorporeal shock wave lithotripsy (ESWL) procedures. The main questions the study aims to answer are: Does retrolaminar block reduce pain intensity during ESWL? Does retrolaminar block improve patient comfort during ESWL? Participants will undergo the following interventions: RLB Group: Retrolaminar block performed under ultrasound guidance prior to ESWL. Sedation Group (S): Standard sedoanalgesia administered. Control Group (C): No additional regional block or sedoanalgesia applied. Participants will be monitored for pain levels, procedural duration, hemodynamic parameters, and the need for additional analgesics. The study aims to determine whether retrolaminar block can serve as a safe and effective analgesic method during ESWL procedures.

Conditions

Urolithiasis

Keywords

Extracorporeal Shock Wave Lithotripsy; Retrolaminar block; Prone position

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain) at four time points: before ESWL (baseline), immediately after the procedure, 30 minutes post-procedure, and 60 minutes post-procedure. This outcome evaluates the analgesic effectiveness of Retrolaminar Block, Sedoanalgesia, or no intervention.

  Assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain) at four time points: baseline, immediately post-procedure, 30 minutes post-procedure, and 60 minutes post-procedure.

Secondary Outcomes (6)

• Rescue Analgesia Requirement

  During and up to 60 minutes post-procedure.

• Heart rate

  Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes

• Adverse Events

  During procedure and up to 60 minutes post-procedure

• Noninvasive Blood Pressure

  Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes

• Oxygen Saturation

  Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes

Study Arms (3)

Group 1: RLB Group - Retrolaminar block prior to ESWL

Participants in this group will receive an ultrasound-guided retrolaminar block prior to prone-position ESWL. The block will be performed using \[specify local anesthetic type and dose\]. All ESWL procedures will be performed according to standard hospital protocols. Patients will be monitored for pain intensity (VAS), vital signs, procedural duration, and any adverse events during and after the procedure. Rescue analgesia will be administered if necessary.

Procedure: Retrolaminar block

Sedation Group - Standard sedoanalgesia

Participants in this group will receive standard sedoanalgesia during prone-position ESWL using \[specify drug(s), dose, and infusion method\]. Pain intensity (VAS), vital signs, procedural duration, and any adverse events will be monitored throughout and after the procedure. Rescue analgesia will be provided as needed according to hospital protocols.

Drug: Sedoanalgesia

Control Group - No additional block or sedoanalgesia

Participants in this group will undergo prone-position ESWL without any additional regional block or sedoanalgesia. Standard monitoring of pain intensity (VAS), vital signs, procedural duration, and any adverse events will be conducted. Rescue analgesia will be provided if clinically indicated.

Other: No Intervention / None

Interventions

Retrolaminar block PROCEDURE

Ultrasound-guided retrolaminar block performed prior to prone-position ESWL. This intervention is applied only to participants in the RLB Group. Patients will be monitored for pain intensity (VAS), vital signs, procedural duration, and any adverse events during and after the procedure. Rescue analgesia will be administered if clinically indicated.

Also known as: RLB Group

Group 1: RLB Group - Retrolaminar block prior to ESWL

Sedoanalgesia DRUG

Standard sedoanalgesia administered during prone-position ESWL. This intervention is applied only to participants in the Sedation Group. Pain intensity (VAS), vital signs, procedural duration, and any adverse events will be monitored. Rescue analgesia will be provided as needed.

Sedation Group - Standard sedoanalgesia

No Intervention / None OTHER

No additional regional block or sedoanalgesia; standard monitoring only. This applies only to participants in the Control Group. Pain intensity (VAS), vital signs, procedural duration, and any adverse events will be monitored. Rescue analgesia will be provided if clinically indicated.

Control Group - No additional block or sedoanalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for ESWL for urinary system stones at Elazığ Fethi Sekin City Hospital. Participants will be assigned to receive Retrolaminar Block, standard sedoanalgesia, or no intervention. Pain intensity, vital signs, procedural parameters, and adverse events will be monitored.

You may qualify if:

• Age ≥ 18 years
• ASA Physical Status I-III
• Undergoing ESWL in prone position
• Provided written informed consent

You may not qualify if:

• ASA Physical Status IV or higher
• Allergy to local anesthetics or sedatives
• Coagulopathy or anticoagulant use
• Local infection at injection site
• Severe spinal deformity or anatomical abnormality preventing block
• Cognitive impairment or inability to use VAS
• Pregnancy
• Chronic opioid use or chronic pain medication
• Emergency ESWL
• Previous open surgery at block site
• Intraoperative hemodynamic instability or severe complications

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Serpil Bayındır, Specialist Physician / Anesthe

CONTACT

+905055493582; serpilbayindir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 17, 2025
• Study Start: September 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)