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Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade (RIBPA)

This study has been completed.
Sponsor:
Information provided by:
Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01075503
First received: February 22, 2010
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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 Intervention
Upper Extremity
Procedure: brachial plexus block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: New Approach for Brachial Plexus Block: Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade

Resource links provided by NLM:


Further study details as provided by Beijing Jishuitan Hospital:

Primary Outcome Measures:
  • Success rate of nerve sensory block [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Success rate of motor block [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075503

Locations
China
Beijing jishuitan hospital
Beijing, China, 100035
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
Principal Investigator: Xiaoguang Zhang, MB Department of anesthesiology, Beijing jishuitan hospital, China
  More Information

No publications provided

Responsible Party: Xin Youqing, Beijing jishuitan hospital, China
ClinicalTrials.gov Identifier: NCT01075503     History of Changes
Other Study ID Numbers: JSTMZ.1
Study First Received: February 22, 2010
Last Updated: February 24, 2010
Health Authority: China: Ethics Committee

Keywords provided by Beijing Jishuitan Hospital:
Supraclavicular
Interscalene
Infraclavicular
Brachial plexus block
Ropivacaine

ClinicalTrials.gov processed this record on November 27, 2014