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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02932670
Other study ID # Montreal General Hospital
Secondary ID
Status Completed
Phase N/A
First received October 12, 2016
Last updated March 21, 2017
Start date October 2016
Est. completion date February 2017

Study information

Verified date March 2017
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.


Description:

The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular ICB. Determination of the minimum effective volume of LA is important because it prevents the administration of an unnecessarily large (and potentially toxic) dose. Furthermore, when multiple blocks need to be performed at the same time in the same patient, knowledge of the minimum effective volume allows to the operator to preserve efficacy without sacrificing safety for each block.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- age between 18 and 70 years

- American Society of Anesthesiologists classification 1-3

- body mass index between 20 and 30

Exclusion Criteria:

- adults who are unable to give their own consent

- pre-existing neuropathy (assessed by history and physical examination)

- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets= 100, International Normalized Ratio= 1.4 or partial prothrombin time = 50)

- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine= 100)

- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases= 100)

- allergy to local anesthetics

- pregnancy

- prior surgery in the infraclavicular region

- chronic pain syndromes requiring opioid intake at home

Study Design


Related Conditions & MeSH terms


Intervention

Other:
costoclavicular nerve block
ultrasound-guided costoclavicular nerve block

Locations

Country Name City State
Canada Montreal General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary success rate minimal composite score of 14 out of 16 0-30 min
See also
  Status Clinical Trial Phase
Completed NCT00997867 - Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks Phase 4
Not yet recruiting NCT04784104 - Comparison of Infraclavicular And Supraclavicular Block Phase 4
Completed NCT02151487 - A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
Active, not recruiting NCT05234541 - Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks