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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02653144 |
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Date of registration:
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08/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block
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Scientific title:
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Double Blinded Randomized Controlled Study Evaluating the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block in Patients Undergoing Ambulatory Shoulder Surgery |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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105 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02653144 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Amaresh Vydyanathan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montefiore Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria :
- ASA 1 and 2
- 18-60 years old
- Patients scheduled for ambulatory arthroscopic or open surgery
Exclusion Criteria:
- ASA 3 and 4
- Pre-existing pain disorder
- Regular consumption of chronic pain medication
- Anatomical abnormalities of upper extremity
- Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
- Known allergy to dexmedetomidine
- Coagulopathy
- Uncontrolled Diabetes
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Opioid Use, Unspecified
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Dexamethasone
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Drug: Ropivacaine
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Primary Outcome(s)
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Opioid Requirements (Morphine Equivalents)
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Time to Discharge From PACU to First Opioid Consumption
[Time Frame: 24-48 hours after surgery]
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Opioid Requirements (Morphine Equivalents)
[Time Frame: 48 hours]
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Return of Motor and Sensory Function
[Time Frame: 24-48 hours after surgery]
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Secondary ID(s)
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2015-5628
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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