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Pectointercostal fascia blocks for Pain (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 hours for 24 hours post-operatively for reporting.

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 more

Awards & 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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