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临床试验/CTRI/2025/04/085876
CTRI/2025/04/085876尚未招募不适用

Comparative Evaluation of Axillary Approach v/s Retroclavicular (RAPTIR) Approach in Ultrasound Guided Brachial Plexus Block for Distal Upper Limb Surgery: A Prospective Randomized Comparative Trial

Sanjay Gandhi Post Graduate Institue of medical sciences,1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
The primary outcome is the performance time expressed in minutes.

研究概览

简要总结

·

Regional anesthesia for upper limb surgery provides many advantages over general anesthesia, especially in orthopedic surgery.The Brachial plexus block (BPB) is less invasive and as equally effective as general anaesthesia to anaesthetize the upper limbs. The most important of them is the control of postoperative pain, which results in decreased postoperative opioid requirements and the patient’s recovery time. With the introduction of the ultrasound-guided technique, the success rate has reached 95-100%. Therefore, a different indicator is required in comparative studies today, and the procedure time is considered as an important indicator after the success rate. There have been no comparative studies between the widely practiced Axillary brachial plexus block and the recently introduced and relatively less practiced  Retroclavicular approach to Infraclavicular brachial plexus block (RAPTIR).Thus we aim to conduct this study to compare various parameters of both these approaches with the main emphasis on the time to perform these blocks.The primary objective is to determine the procedure time which is summation of imaging time and needling time. The secondary objectivesinclude analysis of onset time, block success rate, procedure related pain, NRS (static/dynamic) Score in postoperative period up to 24 hrs, Time to first rescue analgesia, Complications. Following approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from the patients, a randomised comparative study will be conducted over a period of 18 months in patients undergoing distal upper limb surgeries. Patients will be randomly allocated by use of block randomization method using software_” sealed envelope”. The study population will be above years, ASA I,II and III, undergoing distal upper limb surgery. Exclusion criteria includes patient refusal, previous surgery or gross anatomical deformity/Fracture of the clavicle, BMI >30 kg/m2, Systemic or local infection at the needle entry point, Coagulopathy, Severe pulmonary condition, Local anaesthetic allergy, Pre-existing neurologic symptoms in the ipsilateral limb, Pregnancy. As per randomization, patients will be given either axillary block or RAPTIR block with 25 ml of 0.5% Bupivacaine. The primary outcome is the performance time, expressed in minutes. The performance time corresponds to the sum of imaging time and needling time, which both are secondary outcomes. Secondary outcome measures: Onset of block – Measured as Composite score of sensory and motor block (14 out of 16), Success of plexus block, Pain assessment will be done using a 10-cm Numeric Rating Scale immediately after the block and in first 24 hours, Time to first analgesic request, Early and late complications: the incidence of needle-induced paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of LA toxicity will be noted. All patients will be followed at 48 hours after surgery to ask for any delayed complications, such as dyspnea, paresthesia, weaknesses, pain at the puncture site or haematoma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Elective or urgent surgery of the hand wrist forearm American Society of Anaesthesiologists ASA class I to III.

排除标准

  • Patient refusal Previous surgery or gross anatomical deformity/Fracture of the clavicle BMI greater than 30 Systemic or local infection at the needle entry point Coagulopathy Severe pulmonary condition Local anaesthetic allergy Pre-existing neurologic symptoms in the ipsilateral limb Pregnancy.

结局指标

主要结局

The primary outcome is the performance time expressed in minutes.

时间窗: Measured at 15 minutes from the start of the procedure

次要结局

  • Sensory block assessment(Motor block assessment)

研究者

发起方
Sanjay Gandhi Post Graduate Institue of medical sciences,
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Suruchi

Sanjay Gandhi Post Graduate Institue of medical sciences

研究点 (1)

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