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

NCT03270033 | Completed Phase 4

• 1 other identifier: B2017:053
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Shoulder Joint Disorder; Ambulatory Surgical Procedures; Brachial Plexus Block

Keywords

Shoulder Joint; Arthroscopy; Ambulatory surgical procedures; Pain, Postoperative; Brachial Plexus Block; Corticosteroid; Dexamethasone; Dexmedetomidine; Bupivacaine; Alpha 2 agonist; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia after ISB

  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.

  Time-to-event outcome measure, assessed up to the end of postoperative day 3 (approximately 84 hours from performance of the block

Secondary Outcomes (7)

• Block Success or Failure

  Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block.

• Cumulative Analgesic Consumption in the post anesthesia care unit

  "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)

• Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred

  "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)

• Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review

  Assessed at telephone follow up on postoperative day one and chart review

• New Persistent Neurologic Symptoms

  Assessed at postoperative day 14

Other Outcomes (2)

• Intraoperative and post anesthesia care unit use of cardiovascular medications, as recorded in the patient's chart

  Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block

• Adverse events previously related to the inter scalene block and unlikely related to dexamethasone or dexmedetomidine, as recorded in the patient's chart.

  Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block

Study Arms (3)

Dexamethasone

ACTIVE COMPARATOR

4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

Drug: Dexamethasone

Dexmedetomidine

ACTIVE COMPARATOR

50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

Drug: Dexmedetomidine

Dexamethasone and Dexmedetomidine

ACTIVE COMPARATOR

4 milligrams dexamethasone and 50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

Drug: Dexamethasone; Drug: Dexmedetomidine

Interventions

Dexamethasone DRUG

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.

Also known as: Dexamethasone Omega Unidose (Omega Laboratories Limited), Dexamethasone Sodium Phosphate USP (1 millilitre vial)

Dexamethasone; Dexamethasone and Dexmedetomidine

Dexmedetomidine DRUG

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.

Also known as: Precedex (Hospira Healthcare Corporation), Dexmedetomidine Hydrochloride for Injection

Dexamethasone and Dexmedetomidine; Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Pan Am Surgical Centre

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (29)

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  PMID: 33598889 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; dexamethasone 21-phosphate; Dexmedetomidine; Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Thomas C Mutter, MD MSc

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: September 18, 2017
• Primary Completion: April 14, 2018
• Study Completion: October 13, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CA (1)