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Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology (SPIFFY Trial)
Phase 4
Waitlist Available
Led By Wing Lam
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 hours for 24 hours post-operatively
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing if using a special technique can help heart surgery patients manage pain better and need fewer strong painkillers.
Eligible Conditions
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 hours for 24 hours post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 hours for 24 hours post-operatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Opioid consumption
Secondary study objectives
ICU length of stay
Local anesthetic systemic toxicity effects
Opioid consumption in 24 hours
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
This group of patients will undergo placement of US guided pectointercostal fascia blocks.
Group II: PlaceboPlacebo Group1 Intervention
The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,394 Total Patients Enrolled
8 Trials studying Pain
1,768 Patients Enrolled for Pain
Wing LamPrincipal InvestigatorUniversity of Alberta