Urolithiasis
Conditions
Keywords
Extracorporeal Shock Wave Lithotripsy, Retrolaminar block, Prone position
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.
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.
Interventions
DRUGSedoanalgesia
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.
PROCEDURERetrolaminar 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.
OTHERNo 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.
Sponsors
Elazıg Fethi Sekin Sehir Hastanesi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes | Heart rate will be monitored throughout the ESWL procedure and recovery period to assess hemodynamic stability. |
| Adverse Events | During procedure and up to 60 minutes post-procedure | Any adverse events related to ESWL, sedation, or block will be documented. |
| Rescue Analgesia Requirement | During and up to 60 minutes post-procedure. | 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 |
| Oxygen Saturation | Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes | Oxygen saturation will be monitored to ensure adequate oxygenation and patient safety throughout the procedure and recovery. |
| Global Assessment of Quality of Life (Physician's Global Assessment) | Within 1 hour after ESWL procedure | Physicians will provide a global assessment of patient well-being using a 10-point numeric rating scale (0 = poorest outcome, 10 = best outcome). |
| Noninvasive Blood Pressure | Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes | Noninvasive Blood Pressure will be monitored to assess hemodynamic stability |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSerpil Bayındır, Specialist Physician / Anesthe
Outcome results
None listed