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NCT Number: NCT07177625

Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

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.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location contact

Serpil Bayındır, MD

CONTACT

[email protected]

05055493582

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retrolaminar block

Procedure

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.

Other names: RLB Group

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rescue Analgesia Requirement

    Time frame: 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

  2. Heart rate

    Time frame: 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.

  3. Adverse Events

    Time frame: During procedure and up to 60 minutes post-procedure

    Any adverse events related to ESWL, sedation, or block will be documented.

  4. Noninvasive Blood Pressure

    Time frame: 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

  5. Oxygen Saturation

    Time frame: 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.

  6. Global Assessment of Quality of Life (Physician's Global Assessment)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Serpil Bayındır, Specialist Physician / Anesthe

CONTACT

[email protected]

+905055493582

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

Assessment of Patient Comfort and Analgesic Efficacy of Retrolaminar Block During Extracorporeal Shock Wave Lithotripsy : An Observational Prospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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