Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade (RIBPA)

• ClinicalTrials.gov Identifier: NCT01075503
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: February 25, 2010
• Sponsor: Beijing Jishuitan Hospital
• Information provided by: Beijing Jishuitan Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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%

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

• Responsible Party: Xin Youqing, Beijing jishuitan hospital, China
• ClinicalTrials.gov Identifier: NCT01075503
• Other Study ID Numbers: JSTMZ.1
• First Posted: February 25, 2010
• 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:

Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents