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临床试验/CTRI/2024/11/076323
CTRI/2024/11/076323已完成Phase 3 4

Comparison of Hemidiaphragmatic Paresis after ultrasoundguided Costoclavicular versus Supraclavicular brachial plexus block in elective upper limb surgeries - A Randomised controlled trial

NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月18日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to

研究概览

简要总结

•      Ultrasound-guided supraclavicular (SC) and infraclavicular (IC) approaches have become increasingly common brachial plexus blocks (BPBs) for upper-extremity surgery, because of the greater safety of these methods due to real-time ultrasound guidance and faster onset times.

•      The occurrence of hemidiaphragmatic paresis depends on site of injection with the incidence being 45-100% for interscalene brachial plexus block, 28-67% for supraclavicular brachial plexus block and 13-24% for lateral sagittal infraclavicular brachial plexus block.

•      Hemidiaphragmatic paresis (HDP) is a frequent complication of the brachial plexus block, caused by unintentional blockade of the phrenic nerve, especially when the block is performed above the clavicle.

•      The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space

•      The CCB can provide a successful and rapid onset of the blockade with a single injection of a relatively small volume of local anaesthetic.

•      The costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anesthesia, same as supraclavicular block and also there are chances of hemidiaphragmatic paresis. However the incidence of hemidiaphragmatic paresis after costoclavicular block is not clearly known.

•       HDP can be easily tolerated in normal patients but it can cause complications in COPD patients. Hence our study to find out incidence of hemidiaphragmatic paresis after CCB will be useful.

•      As there are very few studies comparing the hemidiaphragmatic paresis after ultrasound- guided supraclavicular and costoclavicular brachial plexus block in elective upper limb surgeries, we would like to conduct this study comparing the two blocks.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator 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

  • Patient scheduled for elective upper limb surgery
  • ASA class 1,2,3
  • BMI less than 30 kg/m2.

排除标准

  • 1.Patients unable to cooperate or consent to surgery 2.Preexisting neuropathy 3.Significant pulmonary disease 4.Contralateral phrenic nerve palsy or diaphragmatic dysfunction 5.Allergy to local anaesthetics 6.Infection at needle insertion site.

结局指标

主要结局

To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to

时间窗: To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to | • Diaphragmatic excursion measurement using M-mode during | -Normal breathing, | - Deep breathing and | -Voluntary sniff manoeuvre | At intervals of 15 minutes and 30 minutes post block

• Diaphragmatic excursion measurement using M-mode during

时间窗: To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to | • Diaphragmatic excursion measurement using M-mode during | -Normal breathing, | - Deep breathing and | -Voluntary sniff manoeuvre | At intervals of 15 minutes and 30 minutes post block

-Normal breathing,

时间窗: To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to | • Diaphragmatic excursion measurement using M-mode during | -Normal breathing, | - Deep breathing and | -Voluntary sniff manoeuvre | At intervals of 15 minutes and 30 minutes post block

- Deep breathing and

时间窗: To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to | • Diaphragmatic excursion measurement using M-mode during | -Normal breathing, | - Deep breathing and | -Voluntary sniff manoeuvre | At intervals of 15 minutes and 30 minutes post block

-Voluntary sniff manoeuvre.

时间窗: To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to | • Diaphragmatic excursion measurement using M-mode during | -Normal breathing, | - Deep breathing and | -Voluntary sniff manoeuvre | At intervals of 15 minutes and 30 minutes post block

次要结局

  • To compare the block characteristics between ultrasound guided supraclavicular brachial plexus block and ultrasound guided costoclavicular brachial plexus block for elective upper limb surgeries with respect to(1 Block performance time)

研究者

发起方
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ajinkya Kalbande

NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital

研究点 (1)

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