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Clinical Trials in Turkey / NCT07177625
Starting soon Observational

Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

NCT07177625 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-09-15
Last updated
2025-09-17

Condition(s) studied

Urolithiasis

Investigational drug(s) / intervention(s)

Retrolaminar blockSedoanalgesiaNo Intervention / None

Retrolaminar block: 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.

Sedoanalgesia: 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.

No Intervention / None: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * ASA Physical Status I-III * Undergoing ESWL in prone position * Provided written informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Elazığ Fethi Sekin City Hospital Elâzığ Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177625 on ClinicalTrials.gov ↗ ← All trials in Turkey