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Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

ConditionUrolithiasis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElazıg Fethi Sekin Sehir Hastanesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

ASA Physical Status I-III

Undergoing ESWL in prone position

Provided written informed consent

Disqualifiers

ASA Physical Status IV or higher

Allergy to local anesthetics or sedatives

Coagulopathy or anticoagulant use

Local infection at injection site

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Retrolaminar block

    Procedure/Surgery

    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

    Drug

    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

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group 1: RLB Group - Retrolaminar block prior to ESWL1 intervention
Group B: Sedation Group - Standard sedoanalgesia1 intervention
Group C: Control Group - No additional block or sedoanalgesia1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elazıg Fethi Sekin Sehir Hastanesi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: