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

NCT02426736 | Completed Phase 4

• 1 other identifier: B2015:016
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Disorder of Shoulder

Keywords

Shoulder Joint; Arthroscopy; Ambulatory surgical procedures; Pain, Postoperative; Brachial Plexus Block; Corticosteroid; Dexamethasone; Bupivacaine; Perineural

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia after interscalene 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.

  Time-to-event outcome measure, assessed up to the end of postoperative day 2 (approximately 60 hours from performance of the block).

Secondary Outcomes (14)

• 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.

• Severity of pain at the time the primary outcome occurred, measured on an 11-point numerical rating score.

  Assessed at the time that the primary outcome occurs, an expected average of 20 hours after performance of the block.

• Cumulative Analgesic Consumption in the post anesthesia care unit, measured as equivalent milligrams of morphine.

  "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).

• Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred, measured as equivalent milligrams of morphine.

  "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).

• Postoperative Nausea and/or vomiting measured on an 11-point numerical rating score.

  Assessed at telephone follow up on postoperative day one.

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 5 hours after the performance of the block.

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

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

Study Arms (4)

Low dose intravenous dexamethasone

ACTIVE COMPARATOR

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

High dose intravenous dexamethasone

ACTIVE COMPARATOR

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

Low dose perineurial dexamethasone

ACTIVE COMPARATOR

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

High dose perineurial dexamethasone

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

High dose intravenous dexamethasone; High dose perineurial dexamethasone; Low dose intravenous dexamethasone; Low dose perineurial dexamethasone

Bupivacaine DRUG

High dose intravenous dexamethasone; High dose perineurial dexamethasone; Low dose intravenous dexamethasone; Low dose perineurial dexamethasone

Interscalene brachial plexus block PROCEDURE

Performed with real time ultrasound guidance.

High dose intravenous dexamethasone; High dose perineurial dexamethasone; Low dose intravenous dexamethasone; Low dose perineurial dexamethasone

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 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Pan Am Surgical Centre

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (24)

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• Holland D, Amadeo RJJ, Wolfe S, Girling L, Funk F, Collister M, Czaplinski E, Ferguson C, Leiter J, Old J, MacDonald P, Dufault B, Mutter TC. Effect of dexamethasone dose and route on the duration of interscalene brachial plexus block for outpatient arthroscopic shoulder surgery: a randomized controlled trial. Can J Anaesth. 2018 Jan;65(1):34-45. doi: 10.1007/s12630-017-0989-7. Epub 2017 Nov 10.

  PMID: 29127558 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Bupivacaine

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; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 27, 2015
• Study Start: June 25, 2015
• Primary Completion: July 12, 2016
• Study Completion: January 12, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)