Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

This study has been completed.
Sponsor:
Information provided by:
Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01334619
First received: April 7, 2011
Last updated: April 12, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Upper Extremity Injury Trauma
Procedure: appropriate volume of 0.5% ropivacaine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

Resource links provided by NLM:


Further study details as provided by Beijing Jishuitan Hospital:

Primary Outcome Measures:
  • VAS of brachial plexus innervated area [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    effect and side effects of the present block approach for brachial plexus.


Secondary Outcome Measures:
  • medium effective ropivacaine volume [ Time Frame: about 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ropivacaine volume titration 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.
Other Name: Naropin

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334619

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, Beijing, China
  More Information

No publications provided

Responsible Party: Xiaoguang Zhang, Department of Anesthesiology, Beijing Jishuitan Hosptial
ClinicalTrials.gov Identifier: NCT01334619     History of Changes
Other Study ID Numbers: JSTMZ.2
Study First Received: April 7, 2011
Last Updated: April 12, 2011
Health Authority: China: Ethics Committee

Keywords provided by Beijing Jishuitan Hospital:
Anesthetic techniques,regional
Drug delivery,volume
Anesthetic, local: ropivacaine

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014