A Randomized double-blind study to compare the analgesic efficacy of Ultrasound guided supra-inguinal versus conventional infra-inguinal approach for fascia iliaca compartment block in patient with hip bone fracture
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the duration of pain relief between supra-inguinal fascia iliaca compartment block (SIFIB) versus infra-inguinal fascia iliaca compartment block (IIFIB) in patient with unilateral hip bone fracture in terms of first dose of rescue analgesic.
研究概览
简要总结
Title: A Randomized Double-Blind Study to Compare the Analgesic Efficacy of Ultrasound-Guided Supra-Inguinal versus Conventional Infra-Inguinal Approach for Fascia Iliaca Compartment Block in Patients with Hip Bone Fracture
Summary: This prospective, randomized, double-blind clinical study, conducted at JNMC, AMU, aims to compare the analgesic effectiveness of ultrasound-guided supra-inguinal (SIFIB)versus infra-inguinal fascia iliaca compartment block (IIFIB) in patients with unilateral hip bone fractures. Hip fractures are common in the elderly and associated with severe pain and complications. The study includes 60 patients, randomly assigned to either SIFIB or IIFIB groups (30 each), to assess pain relief efficacy.
The primary objective is to compare the duration of analgesia based on the time to first rescue analgesic dose. Secondary objectives include evaluating pain scores using the Numerical Rating Scale (NRS), total analgesic consumption over 24 hours, and recording any adverse effects or complications.
This trial emphasizes the importance of early and effective regional analgesia as a safer alternative to opioids and NSAIDs, especially in elderly patients with comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willingness to participate in the study.
- •Patient between 18 to 75 years of age.
- •A radiographically confirmed unilateral hip bone fracture with NRS score more than
- •BMI between 18-30 kilogram per meter square
- •ASA Grade I and II.
排除标准
- •Having suffered from major trauma or fracture of other bone 2)Refusal to participate.
- •Manifesting coagulopathy or deranged INR.
- •Currently on chronic analgesics, 5)A history of allergy to local anesthetics, 6)An infection in the area where FICB was to be performed, 7)Having significant visual, hearing or cognitive impairment 8)History of alcohol or drug abuse 9)Neuro-vascular disorder in the affected leg.
结局指标
主要结局
To compare the duration of pain relief between supra-inguinal fascia iliaca compartment block (SIFIB) versus infra-inguinal fascia iliaca compartment block (IIFIB) in patient with unilateral hip bone fracture in terms of first dose of rescue analgesic.
时间窗: The intensity of pain will be recorded in both groups at the following time points: before the procedure (T0) and at 1hr (T1), 3hr (T2), 12hr (T3), and 24 hr (T4) after the procedure
次要结局
- To compare the degree of pain relief in terms of Numerical Rating Scale(NRS).(•To record analgesic consumption during first 24 hours.)
研究者
Dr Khursheed Jamal
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh