Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

Official title

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

Overview

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

• Procedure 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.
• Drug 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.
• Other 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.

Primary outcome measures

• 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.]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Elazığ Fethi Sekin City Hospital — Elâzığ

Identifiers

NCT: NCT07177625 · FSCH-SBÜ-2025/09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗