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Phase 4 Completed N=182 Randomized Quadruple-blind Treatment

The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block

Shoulder Surgery · Nerve Block
Source: ClinicalTrials.gov NCT02322242 ↗
Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Duration of Sensory Block — 521; 566 minutes
◆ Published Evidence
Established
49citations · ~8 / year
Comparison of the effects of perineural or intravenous dexamethasone on low volume interscalene brachial plexus block: a randomised equivalence trial.
British journal of anaesthesia · 2020 · Likely link

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.

Linked Publications

  • Comparison of the effects of perineural or intravenous dexamethasone on low volume interscalene brachial plexus block: a randomised equivalence trial.
    British journal of anaesthesia · 2020 · 49 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Duration of Sensory Block
521; 566
SECONDARY
Time to First Opioid Consumption
9.1; 9.6
SECONDARY
Duration of Motor Block
18.5; 20.3
SECONDARY
Post-operative Oxygen Saturation on Room Air
96.6; 97.0
SECONDARY
Opioid Consumption
148.8; 167.2
SECONDARY
Numeric Rating Scale for Pain (NRS 0-10)
3.1; 3.4; 4.9; 4.7; 3.3; 3.3
SECONDARY
Postoperative Serum Blood Glucose
6.8; 6.6
SECONDARY
Number of Participants With Nerve Damage From Interscalene Block
0; 0
SECONDARY
Infection
0; 0
SECONDARY
Number of Participants With Postoperative Nausea and/or Vomiting
32; 32

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 30mg oral morphine or equivalent per day
  • Unable to take acetaminophen or celecoxib
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02322242) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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