UrolithiasisNCT07177625
Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL
An observational study of Urolithiasis, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Retrolaminar block and Sedoanalgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 30 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- ASA Physical Status I-III
- Undergoing ESWL in prone position
- Provided written informed consent
Who cannot join
- 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
Show all 11Show fewer
- Pregnancy
- Chronic opioid use or chronic pain medication
- Emergency ESWL
- Previous open surgery at block site
- Intraoperative hemodynamic instability or severe complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, 23100
Serpil Bayındır, MD, 05055493582, serpilbayindir@gmail.com.tr
About this study
Official title: Assessment of Patient Comfort and Analgesic Efficacy of Retrolaminar Block During Extracorporeal Shock Wave Lithotripsy : An Observational Prospective Study
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?
Read more
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.
Read the 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
- Being tested
- Retrolaminar block, Sedoanalgesia, No Intervention / None
- Keywords
- Extracorporeal Shock Wave Lithotripsy, Retrolaminar block, Prone position
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar blockProcedure or surgery
Also called RLB Group
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.
SedoanalgesiaDrug
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 / NoneOther
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 group | Role | What they receive |
|---|---|---|
| Group 1: RLB Group - Retrolaminar block prior to ESWL | 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. Receives: Procedure: Retrolaminar block | |
| Sedation Group - Standard sedoanalgesia | 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. Receives: Drug: Sedoanalgesia | |
| Control Group - No additional block or 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. Receives: Other: No Intervention / None |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: During procedure and up to 60 minutes post-procedure
Noninvasive Blood Pressure
Noninvasive Blood Pressure will be monitored to assess hemodynamic stability
Measured: 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.
Measured: 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).
Measured: Within 1 hour after ESWL procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Bayındır, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177625
- Sponsor's protocol ID
- FSCH-SBÜ-2025/09
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Comfort and Analgesic Efficacy of Retrolaminar Block During Extracorporeal Shock Wave Lithotripsy : An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT07177625
- Acronym / sponsor ID
- FSCH-SBÜ-2025/09
- Conditions
- Urolithiasis
- Keywords
- Extracorporeal Shock Wave Lithotripsy, Retrolaminar block, Prone position
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: RLB Group - Retrolaminar block prior to ESWL | – | Procedure: Retrolaminar blockParticipants 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. |
| Sedation Group - Standard sedoanalgesia | – | Drug: SedoanalgesiaParticipants 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. |
| Control Group - No additional block or sedoanalgesia | – | Other: No Intervention / NoneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- ASA Physical Status I-III
- Undergoing ESWL in prone position
- Provided written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrolaminar blockAlso: RLB GroupUltrasound-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. | Procedure or surgery | Group 1: RLB Group - Retrolaminar block prior to ESWL |
| SedoanalgesiaStandard 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. | Drug | Sedation Group - Standard sedoanalgesia |
| No Intervention / NoneNo 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. | Other | Control Group - No additional block or sedoanalgesia |
Primary outcome
Pain Intensity
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.
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.
6 secondary outcomes
Rescue Analgesia Requirement
Time frame: During and up to 60 minutes post-procedure.
Heart rate
Time frame: Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes
Adverse Events
Time frame: During procedure and up to 60 minutes post-procedure
Noninvasive Blood Pressure
Time frame: Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes
Oxygen Saturation
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)
Time frame: Within 1 hour after ESWL procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serpil Bayındır, Specialist Physician / Anesthe (+905055493582, serpilbayindir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.