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临床试验/CTRI/2025/04/085387
CTRI/2025/04/085387尚未招募2/3 期

Efficacy of femoral nerve block and intravenous fentanyl for ease of positioning during spinal Anesthesia for fracture neck femur surgeries: A randomized comparative study

B J Medical College and Civil Hospital Ahmedabad Government of Gujarat1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
2/3 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 efficacy of analgesia by assessing visual analogue score during positioning for subarachnoid block.

研究概览

简要总结

Fracture femur is common orthopaedic presentation following trauma. It is extremely painful bone injury because periosteum has the lowest pain threshold of the deep somatic structures. The definitive management  is to fix the fracture and spinal anaesthesia is preferred. The only concern is pain which may results in improper position for Subarachnoid block. 

Amongst analgesics, opioids are the gold standard out of which Fentanyl is preferred as it is more potent with rapid onset and short duration of action with less sedation, respiratory depression, nausea and histamine mediated itching as compared to other opioids.

Regional anesthetic techniques have the theoretical advantage of avoiding the systemic effects of opioid analgesia, while providing analgesic that targets pain both at rest (static) and on movement (dynamic).Various peripheral nerve blocks have been used increasingly. Femoral nerve block is popular because it is safe and easy to perform. Being superficial nerve, landmarks are easily identifiable

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age 18-75 years, Either gender, ASA Grade I, II, III, Unilateral fracture neck femur surgery under spinal anaesthesia, Written informed consent from patient, Patient able to understand VAS regarding assessment of pain.

排除标准

  • Patient refusal, ASA Grade IV, V, Local infection at the site of lumbar puncture, Allergy to local anaesthetic agent or fentanyl, Patients having multiple fracture, Patients with neuromuscular disorder, coagulation disorder, H/o drug or alcohol abuse.

结局指标

主要结局

To compare efficacy of analgesia by assessing visual analogue score during positioning for subarachnoid block.

时间窗: Before analgesia,10 min after analgesia,During positioning

次要结局

  • To observe and compare hemodynamic changes, To observe any complication, in perioperative period

研究者

发起方
B J Medical College and Civil Hospital Ahmedabad Government of Gujarat
申办方类型
Government medical college

研究点 (1)

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