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Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03270033
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Mutter, University of Manitoba

Brief Summary:
In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Shoulder Joint Disorder Ambulatory Surgical Procedures Brachial Plexus Block Drug: Dexamethasone Drug: Dexmedetomidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : April 14, 2018
Actual Study Completion Date : October 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone
4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
0.4 millilitres (mL) of 10 milligram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
Other Names:
  • Dexamethasone Omega Unidose (Omega Laboratories Limited)
  • Dexamethasone Sodium Phosphate USP (1 millilitre vial)

Active Comparator: Dexmedetomidine
50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexmedetomidine
0.5 millilitres (mL) of 100 microgram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
Other Names:
  • Precedex (Hospira Healthcare Corporation)
  • Dexmedetomidine Hydrochloride for Injection

Active Comparator: Dexamethasone and Dexmedetomidine
4 milligrams dexamethasone and 50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
0.4 millilitres (mL) of 10 milligram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
Other Names:
  • Dexamethasone Omega Unidose (Omega Laboratories Limited)
  • Dexamethasone Sodium Phosphate USP (1 millilitre vial)

Drug: Dexmedetomidine
0.5 millilitres (mL) of 100 microgram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
Other Names:
  • Precedex (Hospira Healthcare Corporation)
  • Dexmedetomidine Hydrochloride for Injection




Primary Outcome Measures :
  1. Duration of analgesia after ISB [ Time Frame: Time-to-event outcome measure, assessed up to the end of postoperative day 3 (approximately 84 hours from performance of the block ]
    Time from block performance to the first time shoulder pain was experienced after the surgery, rounded to the nearest 0.1 hours, as reported by the participant at telephone follow-up on postoperative day one, or if necessary, postoperative day 2.


Secondary Outcome Measures :
  1. Block Success or Failure [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block. ]
    The block will be considered "failed" if the patient required opioid analgesia for surgical site pain during their stay in the post anesthesia care unit, as determined by the patient's nurse. At our facility, patients are discharged home directly from the post anesthesia care unit.

  2. Cumulative Analgesic Consumption in the post anesthesia care unit [ Time Frame: "Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 2.5 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 4 hours after performance of the block) ]
    Measured as equivalent milligrams of morphine

  3. Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred [ Time Frame: "Change" outcome measure: From discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block), to the occurrence of the primary outcome (an expected average of 28 hours after performance of the block) ]
    Measured as equivalent milligrams of morphine

  4. Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review [ Time Frame: Assessed at telephone follow up on postoperative day one and chart review ]
    Transfer or admission to hospital during the postoperative period between admission to the post anesthesia care unit and telephone follow up on postoperative day one

  5. New Persistent Neurologic Symptoms [ Time Frame: Assessed at postoperative day 14 ]
    Patient will be asked whether they are experiencing any tingling, numbness or weakness in the surgical limb, or hoarseness or dyspnea. Patients answering yes to any of the above will have a detailed telephone assessment and be reassessed by telephone at 6 months postoperatively

  6. Post anesthesia care unit length of stay in minutes [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after performance of the block. ]
    Amount of time between admission and discharge from the post anesthesia care unit.

  7. The QoR-15 questionnaire [ Time Frame: Assessed at postoperative day one. ]
    A standardized and validated 15 item questionnaire consisting exclusively of 11 point integer scale questions (10 = all the time, 0 = none of the time) designed to assess quality of recovery, physical and mental wellbeing in patients recovering from surgery. A total composite score is measured as the total of all 15 individual scores.


Other Outcome Measures:
  1. Intraoperative and post anesthesia care unit use of cardiovascular medications, as recorded in the patient's chart [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block ]
    The use of Intraoperative vasopressors, inotropes, antimuscarinics or antihypertensives at any time between the performance of the block and discharge from the post anesthesia care unit

  2. Adverse events previously related to the inter scalene block and unlikely related to dexamethasone or dexmedetomidine, as recorded in the patient's chart. [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block ]
    The occurrence of seizure, systemic local anesthetic toxicity, pneumothorax, hemothorax, epidural spread of local anesthetic, or hoarse voice at any time between the performance of the block and discharge from the post anesthesia care unit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery
  • Including rotator cuff repair
  • Stabilization procedures
  • Acromioplasty
  • Debridement and distal clavicle excision

Exclusion Criteria:

  • Patient refusal
  • Diabetes
  • Pregnancy
  • Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
  • Sensitivity to local anesthetics, dexamethasone or dexmedetomidine
  • Severe chronic obstructive pulmonary disease
  • Contralateral vocal cord paralysis
  • Contralateral diaphragmatic paralysis
  • Surgical limb brachial plexus neuropathy
  • Interscalene block site infection
  • Systemic glucocorticoids in the last 2 weeks
  • Epidural or intraarticular steroid injection in the past 3 months
  • Chronic opioid use defined as daily use for the last two weeks
  • Active peptic ulcer disease
  • End-stage renal disease
  • Cirrhotic liver disease
  • Ventricular dysfunction
  • Advanced heart block
  • Previous participation in the study.

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): NCT03270033


Locations
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Canada, Manitoba
Pan Am Surgical Centre
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Thomas C Mutter, MD MSc Assistant Professor

Publications:
Montefiore Medical Center; Bronx, New York. The Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016- [cited 2017 March 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02653144 NLM Identifier: NCT02653144
B. P. Koirala Institute of Health Sciences; Dharan, Sunsari, Nepal. Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016- [cited 2017 March 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02787018 NLM Identifier: NCT02787018
Government Medical College and Hospital; Department of Anaesthesia and Intensive Care, Government Medical and Hospital, Chandigarh, India. A randomised double blind study comparing dexmedetomidine with dexamethasone as an adjunct to ropivacaine in ultrasound guided interscalene block for shoulder surgery In: Clinical Trials Registry India [Internet]. New Delhi: database publisher (India). 2015- [cited 2017 March 5]. Available from: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11447 Identifier: CTRI/2015/08/006124

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Responsible Party: Thomas Mutter, Assistant Professor of Anesthesia, University of Manitoba
ClinicalTrials.gov Identifier: NCT03270033    
Other Study ID Numbers: B2017:053
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Mutter, University of Manitoba:
Shoulder Joint
Arthroscopy
Ambulatory surgical procedures
Pain, Postoperative
Brachial Plexus Block
Corticosteroid
Dexamethasone
Dexmedetomidine
Bupivacaine
Alpha 2 agonist
Postoperative analgesia
Additional relevant MeSH terms:
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Joint Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Bupivacaine
Dexamethasone 21-phosphate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics