Retrolaminar Block Analgesia and Patient Comfort During Prone ESWL

Elazıg Fethi Sekin Sehir Hastanesi

Status: Not yet enrolling

Conditions: Urolithiasis

Treatments: Other: No Intervention / None; Drug: Sedoanalgesia; Procedure: Retrolaminar block

Study type: Observational

Funder types: Other

Identifiers

NCT07177625

FSCH-SBÜ-2025/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Group 1: RLB Group - Retrolaminar block prior to ESWL

Description:

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.

Treatment:

Procedure: Retrolaminar block

Sedation Group - Standard sedoanalgesia

Description:

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.

Treatment:

Drug: Sedoanalgesia

Control Group - No additional block or sedoanalgesia

Description:

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.

Treatment:

Other: No Intervention / None