Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade

Upper Extremity Clinical Trial

— RIBPA  

Official title:

New Approach for Brachial Plexus Block: Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075503
• Other study ID #: JSTMZ.1
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 24, 2010
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Brachial plexus block is a frequently used technique for upper extremity surgery. All present approaches and techniques have certain advantages and disadvantages. It's necessary to develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution, 5) causes as few complications as possible, 6) easily place a secured catheter for post-operative analgesia. The investigators established the retrograde infraclavicular brachial plexus block approach. The investigators compared and verified the feasibility, efficacy and safety of this new approach with other classic approaches to brachial plexus block.

Description:

Traditional brachial plexus block approaches have certain limitations. This study evaluated the effectiveness, safety and feasibility of a new retrograde infraclavicular brachial plexus block as compared with interscalene and supraclavicular approaches. 90 patients scheduled for elective upper limb surgery were recruited and randomized into three groups, 30 for each group. Patients of Group A received retrograde infraclavicular block, interscalene (by Winnie) approach for Group B and supraclavicular (by Kulenkampff) approach for Group C. The retrograde infraclavicular block was performed with the insertion point medial to the coracoid process and the needle advanced to ipsilateral interscalene groove. Neurostimulation was used and 40ml of 0.5% ropivacaine were injected. Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30min after local anesthetic injection. The needle insertion depth, angles in coronary and sagittal planes of Group A were also recorded. Success rate of each nerve sensory block, sensory block result, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects are all compared among groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA physical status ?~?

• Scheduled for elective upper extremity surgery

Exclusion Criteria:

• Age <18 yr or >60 yr

• Body weight <50kg or >100kg

• Serious brain, heart, lung, liver, kidney diseases or diabetes mellitus

• Incapability or refusing to be enrolled

• Infection at the site of puncture, skin ulcer

• Coagulopathy

• Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Upper Extremity

Intervention

Procedure:
• brachial plexus block
0.5% Ropivacaine 40ml

Locations

Country	Name	City	State
China	Beijing jishuitan hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of nerve sensory block		30 minutes	Yes
Secondary	Success rate of motor block		30 minutes	Yes