Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL
NCT ID: NCT07177625
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2025-09-15
2025-11-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA Physical Status I-III
* Undergoing ESWL in prone position
* Provided written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Elazıg Fethi Sekin Sehir Hastanesi
OTHER
Responsible Party
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Serpil Bayındır
Specialist Doctor
Locations
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Elazığ Fethi Sekin City Hospital
Elâzığ, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FSCH-SBÜ-2025/09
Identifier Type: -
Identifier Source: org_study_id
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