Phase 4
N=182
The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block
Shoulder Surgery · Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT02322242 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Duration of Sensory Block — 521; 566 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systemic Dexamethasone (Drug); Perineural dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr. Stephen Choi
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02322242). 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.