Effect of Ultrasound-Guided Hematoma Block Versus Intravenous Opioids on Pain Reduction in Patients with Clavicle Fracture: A Prospective Parallel-Group Open-label Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 50 percent reduction in pain score (DVPRS 0–10) at 30 minutes post-intervention
研究概览
简要总结
While IV opioids are an entrenched standard of care, their side effects and delayed onset of action warrant exploration of more effective and safer alternatives. UGHB offers a promising approach to pain management that is both targeted and minimally invasive. To date, there are limited prospective studies comparing UGHB with IV opioids specifically for clavicle fractures in the emergency setting.
This study seeks to fill that gap by conducting a randomized controlled trial comparing the analgesic efficacy, onset, duration, side effects, and patient satisfaction between IV opioids and ultrasound-guided hematoma block in patients presenting to the ED with clavicle fractures.
We hypothesize that UGHB will provide comparable or superior pain relief with fewer side effects and higher patient satisfaction, supporting its broader integration into emergency analgesia protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with acute clavicle fracture (within 24 hours of injury).
- •Radiologically confirmed clavicle fracture.
- •Defence and Veterans Pain Rating Scale (DVPRS) pain score of 7 or more on arrival.
- •Ability to provide informed written consent.
排除标准
- •Known allergy to local anesthetics or opioids.
- •Hemodynamic instability (SBP less than 90 mmHg or HR more than 130 bpm).
- •Polytrauma requiring immediate surgical interventions.
- •Fractures with neurovascular compromise.
- •Open clavicle fractures.
- •History of substance abuse or chronic opioid use.
- •Cognitive impairment or psychiatric illness.
- •interfering with consent or communication Local infection or overlying skin lesions at the proposed injection site.
- •Pregnancy or breastfeeding.
- •Those who do not give consent.
结局指标
主要结局
50 percent reduction in pain score (DVPRS 0–10) at 30 minutes post-intervention
时间窗: 30 minutes
次要结局
- DVPRS scores at 15, 30, 60, and 120 minutes post-intervention(15, 30, 60, and 120 minutes)
- Requirement for rescue analgesia (defined as DVPRS score of 7 or more at 30 min)(30 minutes)
- Incidence of side effects: nausea, vomiting, sedation, respiratory depression, allergic reactions, local anaesthetic systemic toxicity or any other.(120 minutes)
- Time taken to perform Hematoma block (excluding scanning and preparation time)
- Patient satisfaction score at 2 hours (Likert scale 1–5)(120 minutes)
研究者
Sanjeev Kumar Bhoi
All India Institute of Medical Sciences, New Delhi