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.
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.
Study Type
OBSERVATIONAL
Enrollment
90
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.
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 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.
Elazığ Fethi Sekin City Hospital
Elâzığ, Turkey (Türkiye)
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.
Time frame: 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.
Rescue Analgesia Requirement
The need for additional analgesia during and after ESWL will be recorded to evaluate differences between the groups (RLB, Sedoanalgesia, Control). Recorded as type, dose, and timing of additional analgesics
Time frame: During and up to 60 minutes post-procedure.
Heart rate
Heart rate will be monitored throughout the ESWL procedure and recovery period to assess hemodynamic stability.
Time frame: Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes
Adverse Events
Any adverse events related to ESWL, sedation, or block will be documented.
Time frame: During procedure and up to 60 minutes post-procedure
Noninvasive Blood Pressure
Noninvasive Blood Pressure will be monitored to assess hemodynamic stability
Time frame: Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes
Oxygen Saturation
Oxygen saturation will be monitored to ensure adequate oxygenation and patient safety throughout the procedure and recovery.
Time frame: Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes
Global Assessment of Quality of Life (Physician's Global Assessment)
Physicians will provide a global assessment of patient well-being using a 10-point numeric rating scale (0 = poorest outcome, 10 = best outcome).
Time frame: Within 1 hour after ESWL procedure
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