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

NCT03270033 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-04-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Thomas C Mutter, MD MSc · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-04-14
Completion
2018-10-13

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270033 on ClinicalTrials.gov