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Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

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ClinicalTrials.gov Identifier: NCT01334619
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
Beijing Jishuitan Hospital

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
Study Start Date : March 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. VAS of brachial plexus innervated area [ Time Frame: 20 minutes ]
    effect and side effects of the present block approach for brachial plexus.


Secondary Outcome Measures :
  1. medium effective ropivacaine volume [ Time Frame: about 2 months ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Xiaoguang Zhang, Department of Anesthesiology, Beijing Jishuitan Hosptial
ClinicalTrials.gov Identifier: NCT01334619     History of Changes
Other Study ID Numbers: JSTMZ.2
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: February 2010

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

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