跳至主要内容
临床试验/CTRI/2025/04/084254
CTRI/2025/04/084254尚未招募不适用

Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with Supraclavicular approach versus Costoclavicular approach in patients undergoing upper limb surgery- A Prospective Randomized Comparative Study

Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月16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
70
试验地点
1
主要终点
Incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular vs costoclavicular approach

研究概览

简要总结

Upper limb orthopaedic surgeries have shown to fasten and improve clinical outcome of trauma patients. Brachial plexus block is an established mode of anaesthesia and analgesia in upper limb orthopaedic procedures. Hemidiaphragmatic Paralysis (HDP) is a frequent complication of brachial plexus block performed with supraclavicular approach as a result of unintentional blockade of phrenic nerve. It is well tolerated in healthy patients, but can become a critical issue in patients with compromised pulmonary function. Costoclavicular brachial plexus block is an emerging, recently introduced infraclavicular approach, exhibiting an accelerated and reliable blockade. The compact organization of plexus at this level is advantageous as lesser volumes of local anaesthetic is required compared to other approaches of infraclavicular block. In our proposed study we aim to compare incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular approach vs costoclavicular approach.

Primary objective is tocompare the incidence of hemidiaphragmatic paralysis by assessing diaphragmatic function with diaphragm excursion and diaphragm thickness fraction (DTF) using ultrasound and Secondary objectives are: to assess pulmonary function before and after the block using spirometer, breath holding test and cough test, scan time and needle time in minutes, post operative pain using numerical rating scale (NRS), time to first rescue analgesia and any complication/adverse events will be noted.

Following approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from the patients, a prospective randomized comparative study will be conducted will be conducted in Apex Trauma Centre, SGPGIMS. over a period of 18 months. Patients will undergo pre anaesthetic check up and will be prepared as per standard anesthesia practices. Patients will be randomly divided into two groups

Group 1: Brachial plexus block using Costoclavicular approach

Group 2: Brachial plexus block using Supraclavicular approach

Patient will be shifted in the operating room, all routine ASA standard monitors, IV line and supplemental oxygen will be attached. Baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. Blocks will be performed under ultrasound guidance using 25 ml of local anesthetic containing 0.75% ropivacaine and 2% lignocaine in (1:1), scan time and needle time will be noted simultaneously. After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be reassessed for the same baseline parameters and any obvious discomfort, adverse events, complications such as pneumothorax, vascular puncture, local anaesthetic systemic toxicity, hematoma, and Horner’s syndrome will be recorded, if present it will be treated accordingly and the patient will be excluded from the trial. If absent, the patient will be handed over to the surgical team for intervention. IV sedation using dexmedetomidine (loading dose 1mcg/kg over 10 mins, maintenance dose of 0.5mcg/kg/hr) will be started and continued intraoperatively.

After completion of surgery, patient will be shifted to Post Operative ICU for observation. NRS scores for pain and time of requirement of first rescue analgesia will be recorded. Any complications in intraoperative and postoperative period will be noted and intervention will be done accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written and informed consent Age group: 18- 65 years Both genders American Society of Anaesthesiologists (ASA) physical status I or II patients Scheduled for upper limb surgeries (including elbow, forearm, hand, and wrist surgery).

排除标准

  • Patient refusal BMI more than 30kg/m2 Hypersensitivity to local anaesthetics Pre-existing neuropathy on surgical limb Significant pulmonary disease Coagulopathy, sepsis, infection on block site Conversion to general anaesthesia.

结局指标

主要结局

Incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular vs costoclavicular approach

时间窗: 25 minutes

次要结局

  • 1. To assess pulmonary function before & after the block using spirometer, breath holding test & cough test(2. To assess scan time & needle time in minutes in two approaches)

研究者

发起方
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prateek Singh Bais

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

研究点 (1)

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