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

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ClinicalTrials.gov Identifier: NCT02653144
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : July 9, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Amaresh Vydynathan, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Opioid Use, Unspecified Drug: Ropivacaine Drug: Dexmedetomidine Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine and ropivacaine group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Drug: Ropivacaine
local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Other Name: anesthetics

Drug: Dexmedetomidine
local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Other Name: anesthetics

Experimental: dexamethasone and ropivacaine group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Drug: Ropivacaine
local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Other Name: anesthetics

Drug: Dexamethasone
local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Other Name: anesthetics

Active Comparator: ropivacaine only group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Drug: Ropivacaine
local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Other Name: anesthetics




Primary Outcome Measures :
  1. Opioid Requirements (Morphine Equivalents) [ Time Frame: 24 hours ]
    How much opioid did patient ask for within 24 hours post op


Secondary Outcome Measures :
  1. Opioid Requirements (Morphine Equivalents) [ Time Frame: 48 hours ]
    How much opioid did patient ask for within 48 hours post op

  2. Time to Discharge From PACU to First Opioid Consumption [ Time Frame: 24-48 hours after surgery ]
    How long after surgery does patient take to ask for opioid to manage pain

  3. Return of Motor and Sensory Function [ Time Frame: 24-48 hours after surgery ]
    Between 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653144


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Amaresh Vydyanathan, MD Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Amaresh Vydynathan, Montefiore Medical Center:
Publications:

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Responsible Party: Amaresh Vydynathan, Assoc. Prof. Anesthesiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02653144    
Other Study ID Numbers: 2015-5628
First Posted: January 12, 2016    Key Record Dates
Results First Posted: July 9, 2020
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amaresh Vydynathan, Montefiore Medical Center:
post operative pain, Dexmedetomidine, Regional anesthesia
Additional relevant MeSH terms:
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Dexamethasone
Dexmedetomidine
Ropivacaine
Anesthetics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local