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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02993939
Date of registration: 12/12/2016
Prospective Registration: No
Primary sponsor: University of Chile
Public title: Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block ISBvsICB-SSB
Scientific title: A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block
Date of first enrolment: December 2016
Target sample size: 40
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02993939
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Chile
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- age between 18 and 75 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 prothrombin time = 50)

- obstructive or restrictive pulmonary disease (assessed by history and physical
examination)

- 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 (LAs)

- pregnancy

- prior surgery in the neck, infraclavicular region or suprascapular fossa

- chronic pain syndromes requiring opioid intake at home



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Shoulder Injury
Intervention(s)
Procedure: Infraclavicular-suprascapular block
Procedure: Interscalene block
Primary Outcome(s)
Static Pain using numeric scale 0-10 [Time Frame: 30 minutes after arrival to PACU]
Secondary Outcome(s)
Static Pain using numeric scale 0-10 [Time Frame: 24 hrs]
Static Pain using numeric scale 0-10 [Time Frame: 12 hrs after arrival to PACU]
Diaphragm paralysis incidence [Time Frame: 30 minutes after block]
Secondary ID(s)
853/16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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