the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block

Brief Summary
The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.
Brief Title
the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block
Detailed Description
Currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. In general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. However, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. In addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally.

Dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. As a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. Although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. When administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. The safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. Nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.
Completion Date
Completion Date Type
Actual
Conditions
Opioid Use, Unspecified
Eligibility Criteria
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
Inclusion Criteria
Inclusion Criteria :

* ASA 1 and 2
* 18-60 years old
* Patients scheduled for ambulatory arthroscopic or open surgery

Gender
All
Gender Based
false
Keywords
post operative pain, Dexmedetomidine, Regional anesthesia
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
18 Years
NCT Id
NCT02653144
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5628
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
How much opioid did patient ask for within 24 hours post op
Outcome Measure
Opioid Requirements (Morphine Equivalents)
Outcome Time Frame
24 hours
Secondary Outcomes
Outcome Description
How much opioid did patient ask for within 48 hours post op
Outcome Time Frame
48 hours
Outcome Measure
Opioid Requirements (Morphine Equivalents)
Outcome Description
How long after surgery does patient take to ask for opioid to manage pain
Outcome Time Frame
24-48 hours after surgery
Outcome Measure
Time to Discharge From PACU to First Opioid Consumption
Outcome Description
Between 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned.
Outcome Time Frame
24-48 hours after surgery
Outcome Measure
Return of Motor and Sensory Function
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Amaresh Vydyanathan
Investigator Email
avydyana@montefiore.org
Investigator Phone

Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
PAIN, POSTOPERATIVE
POSTOPERATIVE COMPLICATIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
ROPIVACAINE
ANESTHETICS
DEXMEDETOMIDINE
DEXAMETHASONE
ANILIDES
AMIDES
ORGANIC CHEMICALS
ANILINE COMPOUNDS
AMINES
CENTRAL NERVOUS SYSTEM DEPRESSANTS
PHYSIOLOGICAL EFFECTS OF DRUGS
PHARMACOLOGIC ACTIONS
CHEMICAL ACTIONS AND USES
CENTRAL NERVOUS SYSTEM AGENTS
THERAPEUTIC USES
IMIDAZOLES
AZOLES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
PREGNADIENETRIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
STEROIDS, FLUORINATED