Assessment of Patient Comfort and Analgesic Efficacy of Retrolaminar Block During Extracorporeal Shock Wave Lithotripsy : An Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ASA Physical Status I-III
- •Undergoing ESWL in prone position
- •Provided written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Retrolaminar block (Procedure)
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.
干预措施: Sedoanalgesia (Drug)
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.
干预措施: No Intervention / None (Other)
结局指标
主要结局
Pain Intensity
时间窗: 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.
次要结局
- Heart rate(Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes)
- Rescue Analgesia Requirement(During and up to 60 minutes post-procedure.)
- Adverse Events(During procedure and up to 60 minutes post-procedure)
- Noninvasive Blood Pressure(Throughout the ESWL procedure (from initiation until termination, typically 30-90 minutes), with measurements recorded every 10 minutes)
- Oxygen Saturation(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)(Within 1 hour after ESWL procedure)
研究者
Serpil Bayındır
Specialist Doctor
Elazıg Fethi Sekin Sehir Hastanesi