跳至主要内容
临床试验/CTRI/2025/07/092074
CTRI/2025/07/092074尚未招募3 期

Comparison of the efficacy of 0.375percentage versus 0.5percentage of ropivacaine for ultrasound guided brachial plexus block through costoclavicular space approach in patients undergoing forearm and hand surgeries a randomised double blind non inferiority clinical trial

Karnataka Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Sensory and motor blockade

研究概览

简要总结

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 . Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered, while maintaining a consistent anatomical relationship with each other

Brachial plexus blockade (BPB) thorough the costoclavicular space block is  widely used anaesthesia technique nowadays in the upper limb surgery . Previously peripheral never block was given with Perineural injections guided by surface anatomy or electrical nerve stimulation but recently the ultrasound guided are more successful than injections guided by surface anatomy or electrical neurostimulation.The classical approaches to BPB include interscalene, supraclavicular, infraclavicular, and axillary approaches.

Recently, with the advances in technology ultrasonography guidance has got more attention and has been used to give the BPB through the costoclavicular space (CCS) and considered  as an alternative access pathway to BPB. The CCS is located between the clavicle and the first rib, deep behind the middle of the clavicle.The CCS was introduced as a feasible pathway for BPB by Dahlstrom and Olinger in 2012 in their study of thoracic outlet syndrome,which was later confirmed in a 2016 autopsy study by Sala–Blanch et al.Subsequent studies using the ultrasound-guided CCS approach to BPB, found that the compact anatomy of the CCS had little interindividual variability and allowed for simple performance with few complications and a high success rate, all of which increases the feasibility for continuous nerve blockade through this approach.In recent years, few studies have applied this approach to special groups of individuals, such as pediatric and obese patients, and reported satisfactory results.

In most of these studies, 0.5% ropivacaine was used but the recent research has shown effective ultrasound-guided supraclavicular BPB using lower local anesthetic concentrationsof ropivacaine and the  data  obtained from few articles provided an information that 0.375% ropivacaine may be effective when given in the CCS. As the risk of systemic (LAST) and direct neurotoxicity increases with higher concentrationsof the drug chances of inadvertentvascukar and pleural injuries may be associated with the block, so we felt it is very  important to understand if a lower concentration of ropivacaine can be used for BPB in the CCS under the ultrasound guidance. Hence, the purpose of this study is to compare the efficacy of 0.375% ropivacaine with 0.5% ropivacaine in ultrasound-guided BPB through the CCS. Our hypothesis is that 0.375% ropivacaine would be noninferior to 0.5% ropivacaine in producing successful BPB when given in the CCS under the ultrasound guidance.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with upper limb bone fracture ASA 1 and 2.

排除标准

  • Patients with sensory or motor defecits
  • Allergic to local anaesthetics
  • Prior surgery in the infra clavicular fossa
  • Bleeding tendencies and coagulopathies
  • Infection at the site of injection
  • History of cerebrovascular accidents
  • Patients with emphysema or COPD.

结局指标

主要结局

Sensory and motor blockade

时间窗: Every five minutes upto thirty minutes from the injection of drug

次要结局

  • Time taken for reversal of sensory & motor blockade & appearance of pain(Every one hour till the patient is able to gain the sensations & motor power)

研究者

发起方
Karnataka Medical College and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Kirana G K

Karnataka Medical College and Research Institute Hubballi

研究点 (1)

Loading locations...

相似试验