An observational study in Urolithiasis, sponsored by Elazıg Fethi Sekin Sehir Hastanesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Elazıg Fethi Sekin Sehir Hastanesi · Observational
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.
253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.
This study's planned enrollment of 90 is below the median of 150 across 65 observational studies indexed under Urolithiasis.
Browse Urolithiasis studies →Elazıg Fethi Sekin Sehir Hastanesi is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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
Plan to share: No
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Elazıg Fethi Sekin Sehir Hastanesi