NCT07177625

Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

Assessment of Patient Comfort and Analgesic Efficacy of Retrolaminar Block During Extracorporeal Shock Wave Lithotripsy : An Observational Prospective Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Elazıg Fethi Sekin Sehir Hastanesi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, observational study aims to investigate the effect of retrolaminar block (RLB) on analgesic efficacy and patient comfort during extracorporeal shock wave lithotripsy (ESWL). Adult patients scheduled for ESWL will be enrolled and allocated into three groups: 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. Pain intensity will be assessed using the Numeric Rating Scale (0-10) at multiple time points during and after the procedure. Procedural duration, hemodynamic parameters, and need for rescue analgesics will also be recorded. Patient comfort and satisfaction will be evaluated immediately post-procedure and at recovery. Safety outcomes, including adverse events related to RLB or sedoanalgesia, will be monitored. The study seeks to determine whether retrolaminar block is a safe and effective analgesic technique for ESWL, potentially improving patient comfort while reducing systemic analgesic requirements.

Conditions

• Urolithiasis

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	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.
OTHER	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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-11-15
• Completion: 2025-11-30
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: Turkey (Türkiye)