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Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT02426736
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Mutter, University of Manitoba

Brief Summary:
In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Disorder of Shoulder Drug: Dexamethasone Drug: Bupivacaine Procedure: Interscalene brachial plexus block Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dexamethasone Dose and Route on Duration of Interscalene Brachial Plexus Block for Outpatient Arthroscopic Shoulder Surgery - A Randomized Controlled Trial
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : July 12, 2016
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low dose intravenous dexamethasone
4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
Drug: Bupivacaine
Procedure: Interscalene brachial plexus block
Performed with real time ultrasound guidance.

Active Comparator: High dose intravenous dexamethasone
8 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
Drug: Bupivacaine
Procedure: Interscalene brachial plexus block
Performed with real time ultrasound guidance.

Active Comparator: Low dose perineurial dexamethasone
4 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
Drug: Bupivacaine
Procedure: Interscalene brachial plexus block
Performed with real time ultrasound guidance.

Active Comparator: High dose perineurial dexamethasone
8 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Drug: Dexamethasone
Drug: Bupivacaine
Procedure: Interscalene brachial plexus block
Performed with real time ultrasound guidance.




Primary Outcome Measures :
  1. Duration of analgesia after interscalene block [ Time Frame: Time-to-event outcome measure, assessed up to the end of postoperative day 2 (approximately 60 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. Severity of pain at the time the primary outcome occurred, measured on an 11-point numerical rating score. [ Time Frame: Assessed at the time that the primary outcome occurs, an expected average of 20 hours after performance of the block. ]
    11-point numerical rating score, with integers from 0 to 10 where 0 represents no pain and 10 represents worst imaginable pain. As reported by telephone follow up.

  3. Cumulative Analgesic Consumption in the post anesthesia care unit, measured as equivalent milligrams of morphine. [ Time Frame: "Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 3 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block). ]
  4. Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred, measured as equivalent milligrams of morphine. [ 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 20 hours after performance of the block). ]
  5. Postoperative Nausea and/or vomiting measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one. ]
    11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since arrival to the post anesthesia care unit.

  6. First postoperative night Sleep Quality, measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one. ]
    11-point numerical rating score, with integers from 0 to 10 where 0 represents a very poor sleep and 10 represents a very restful night's sleep.

  7. Observed postoperative Dyspnea, as recorded in the post anesthesia care unit record. [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block. ]
    As observed and recorded by the post anesthesia care unit nurse during the patient's stay in the post anaesthesia care unit.

  8. Subjective postoperative Dyspnea, measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one. ]
    11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since admission to the post anesthesia care unit.

  9. Restlessness and/or Anxiety, measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one. ]
    11-point numerical rating score, with integers from 0 to 10 where 0 represents the symptom was completely absent and 10 represents the symptom was present the entire time since admission to the post anesthesia care unit.

  10. Motor and/or Sensory Block Dissatisfaction, measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one ]
    11-point numerical rating score, with integers from 0 to 10 where 10 represents complete dissatisfaction and 0 represents no dissatisfaction.

  11. Likelihood of choosing this method of analgesia again, measured on an 11-point numerical rating score. [ Time Frame: Assessed at telephone follow up on postoperative day one ]
    11-point numerical rating score, with integers from 0 to 10 where 10 "would for sure choose this method again", and 0 represents "would for sure not choose this method again".

  12. Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review. [ Time Frame: Assessed at telephone follow up and chart review on postoperative day one. ]
    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.

  13. 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 be reassessed at 6 months postoperatively.

  14. Post anesthesia care unit length of stay in minutes [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after performance of the block. ]
    Amount of time between admission and discharge from the post anesthesia care unit.


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 5 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, as recorded in the patient's chart. [ Time Frame: Assessed at discharge from the post anesthesia care unit, an expected average of 5 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 or dexamethasone
  • 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
  • International normalized ratio (INR) > 1.5
  • Active peptic ulcer disease
  • End-stage renal disease
  • Cirrhotic liver disease
  • 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): NCT02426736


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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Mutter, Assistant Professor of Anesthesia, University of Manitoba
ClinicalTrials.gov Identifier: NCT02426736    
Other Study ID Numbers: B2015:016
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Thomas Mutter, University of Manitoba:
Shoulder Joint
Arthroscopy
Ambulatory surgical procedures
Pain, Postoperative
Brachial Plexus Block
Corticosteroid
Dexamethasone
Bupivacaine
Perineural
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Bupivacaine
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents