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Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade (RIBPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075503
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:
Beijing Jishuitan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Upper Extremity Procedure: brachial plexus block Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: New Approach for Brachial Plexus Block: Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade
Study Start Date : March 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: retrograde infraclavicular
Patients were received retrograde infraclavicular brachial plexus block.
Procedure: brachial plexus block
0.5% Ropivacaine 40ml
Other Name: NAROPIN® 1.0%

Active Comparator: interscalene
Patients were received interscalene brachial plexus block.
Procedure: brachial plexus block
0.5% Ropivacaine 40ml
Other Name: NAROPIN® 1.0%

Active Comparator: supraclavicular
Patients were received supraclavicular brachial plexus block.
Procedure: brachial plexus block
0.5% Ropivacaine 40ml
Other Name: NAROPIN® 1.0%




Primary Outcome Measures :
  1. Success rate of nerve sensory block [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Success rate of motor block [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075503


Locations
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China
Beijing jishuitan hospital
Beijing, China, 100035
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
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Principal Investigator: Xiaoguang Zhang, MB Department of anesthesiology, Beijing jishuitan hospital, China
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Responsible Party: Xin Youqing, Beijing jishuitan hospital, China
ClinicalTrials.gov Identifier: NCT01075503    
Other Study ID Numbers: JSTMZ.1
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010
Keywords provided by Beijing Jishuitan Hospital:
Supraclavicular
Interscalene
Infraclavicular
Brachial plexus block
Ropivacaine
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents