NCT02322242

Brief Summary

A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone. Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

4 years

First QC Date

December 16, 2014

Results QC Date

November 11, 2019

Last Update Submit

July 6, 2020

Conditions

Shoulder SurgeryNerve Block

Outcome Measures

Primary Outcomes (1)

  • Duration of Sensory Block

    Defined as time from completion of block procedure to NRS for pain \> 0 (in hours)

    1 day postoperative

Secondary Outcomes (9)

  • Time to First Opioid Consumption

    1 day postoperative

  • Duration of Motor Block

    1 day postoperative

  • Post-operative Oxygen Saturation on Room Air

    1 hour postoperative

  • Opioid Consumption

    7 days postoperative

  • Numeric Rating Scale for Pain (NRS 0-10)

    7 days postoperative

  • +4 more secondary outcomes

Study Arms (2)

Perineural Dexamethasone

ACTIVE COMPARATOR

ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)

Drug: Perineural dexamethasone

Systemic Dexamethasone

OTHER

ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)

Drug: Systemic Dexamethasone

Interventions

Systemic DexamethasoneDRUG

Intravenous infusion of dexamethasone (4mg)

Also known as: Dexamethasone Sodium Phosphate Injection
Systemic Dexamethasone
Perineural dexamethasoneDRUG

Perinerual administration of dexamethasone (4mg)

Also known as: Dexamethasone Sodium Phosphate Injection
Perineural Dexamethasone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre, Toronto Western Hospital and Women's College Hospital.
  • ASA functional status class I to III
  • Age 18 to 80 years
  • BMI ≤ 35 kg/m2

You may not qualify if:

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI \> 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume \< 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  • Pregnant or nursing females
  • Chronic opioid use defined as \> 30mg oral morphine or equivalent per day
  • Unable to take acetaminophen or celecoxib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • McHardy PG, Singer O, Awad IT, Safa B, Henry PDG, Kiss A, Au SK, Kaustov L, Choi S. Comparison of the effects of perineural or intravenous dexamethasone on low volume interscalene brachial plexus block: a randomised equivalence trial. Br J Anaesth. 2020 Jan;124(1):84-91. doi: 10.1016/j.bja.2019.08.025. Epub 2019 Oct 5.

    PMID: 31591018DERIVED

MeSH Terms

Interventions

dexamethasone 21-phosphate

Results Point of Contact

Title
Dr. Stephen Choi
Organization
Sunnybrook Health Sciences Centre
stephen.choi@sunnybrook.ca
4164804864

Study Officials

  • Stephen Choi, MD,FRCPC,MSc

    SunnybrookHealth Sciences Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR INVESTIGATOR
PI Title
Assistant Professor and Staff Anesthetist, Department of Anesthesia

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

July 15, 2020

Results First Posted

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)