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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02190760
Other study ID # HYMC-13.7.14
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 13, 2014
Last updated July 13, 2014
Start date September 2014
Est. completion date September 2016

Study information

Verified date July 2014
Source Hillel Yaffe Medical Center
Contact Anatoly Stav, MD
Phone 972-4-6304687
Email stav@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pre-surgical patients for arthroscopic or open shoulder surgery

Exclusion Criteria:

- Skin infection near block site

- Allergy to local anesthetics

- Peripheral neuropathy

- Proven opioid dependency

- Coagulopathy

- Dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone

Bupivacaine


Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy DxaM Perineural Duration of motor and sensory block. One day No
Secondary Efficacy of Systemic DxaM Duration of motor and sensory block One day No
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