Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade (RIBPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity
• Intervention / Treatment: Procedure: brachial plexus block

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100035
    • Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: retrograde infraclavicular; Patients were received retrograde infraclavicular brachial plexus block.	Procedure: brachial plexus block; 0.5% Ropivacaine 40ml; Other Names: NAROPIN® 1.0%
Active Comparator: interscalene; Patients were received interscalene brachial plexus block.	Procedure: brachial plexus block; 0.5% Ropivacaine 40ml; Other Names: NAROPIN® 1.0%
Active Comparator: supraclavicular; Patients were received supraclavicular brachial plexus block.	Procedure: brachial plexus block; 0.5% Ropivacaine 40ml; Other Names: NAROPIN® 1.0%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of nerve sensory block	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Success rate of motor block	30 minutes

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Principal Investigator: Xiaoguang Zhang, MB, Department of anesthesiology, Beijing jishuitan hospital, China

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2010
• Last Update Submitted That Met QC Criteria: February 24, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Ropivacaine; Brachial plexus block; Supraclavicular; Interscalene; Infraclavicular
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: JSTMZ.1