Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade

NCT ID: NCT01075503

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Upper Extremity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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retrograde infraclavicular

Patients were received retrograde infraclavicular brachial plexus block.

Group Type EXPERIMENTAL

brachial plexus block

Intervention Type PROCEDURE

0.5% Ropivacaine 40ml

interscalene

Patients were received interscalene brachial plexus block.

Group Type ACTIVE_COMPARATOR

brachial plexus block

Intervention Type PROCEDURE

0.5% Ropivacaine 40ml

supraclavicular

Patients were received supraclavicular brachial plexus block.

Group Type ACTIVE_COMPARATOR

brachial plexus block

Intervention Type PROCEDURE

0.5% Ropivacaine 40ml

Interventions

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brachial plexus block

0.5% Ropivacaine 40ml

Intervention Type PROCEDURE

Other Intervention Names

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NAROPIN® 1.0%

Eligibility Criteria

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Inclusion Criteria

* ASA physical status Ⅰ\~Ⅱ
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing jishuitan hospital, China

Principal Investigators

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Xiaoguang Zhang, MB

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology, Beijing jishuitan hospital, China

Locations

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Beijing jishuitan hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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JSTMZ.1

Identifier Type: -

Identifier Source: org_study_id

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