Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

Upper Extremity Injury Trauma Clinical Trial

Official title:

Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334619
• Other study ID #: JSTMZ.2
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2011
• Last updated: April 12, 2011
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: February 2010
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.

Description:

Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Elected upper extremity operations

• BMI 17~30kg/m2

• ASA I/II

Exclusion Criteria:

• Infection at injection site

• Sepsis

• Coagulation Dysfunction

• Phrenic nerve palsy

• Pneumothorax

• Recurrent laryngeal nerve palsy

• Clavicle fracture combined with nerve damage

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Arm Injuries
• Upper Extremity Injury Trauma

Intervention

Procedure:
• appropriate volume of 0.5% ropivacaine
initial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed.

Locations

Country	Name	City	State
China	Beijing jishuitan hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS of brachial plexus innervated area	effect and side effects of the present block approach for brachial plexus.	20 minutes	No
Secondary	medium effective ropivacaine volume	The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. EV95 was calculated using probit regression.	about 2 months	No