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Nerve Block for Postoperative Pain (SPGB Trial)

Phase 4

Waitlist Available

Led By Dr. Kesava Reddy, MD

Research Sponsored by Hamilton Health Sciences Corporation

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 through study completion, approximately 1 year

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to determine if adding a nerve block during pituitary surgery can help manage pain better after the surgery. Patients will receive either Bupivacaine or a placebo during surgery and will

Who is the study for?

This trial is for individuals undergoing minimally invasive pituitary surgery who need postoperative pain management. Participants must meet certain health criteria to be eligible, but specific inclusion and exclusion details are not provided.

What is being tested?

The study tests the effectiveness of a nerve block with Bupivacaine-Epinephrine solution versus a placebo (saline) in managing post-surgery pain. Patients' pain levels will be monitored over the first day after surgery to see if this approach reduces their pain medication needs.

What are the potential side effects?

Possible side effects may include reactions at the injection site, such as discomfort or swelling, and systemic effects like dizziness or heart rate changes due to Bupivacaine-Epinephrine. Placebo injections typically have no active side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative pain score

Secondary study objectives

Analgesic requirement

Length of stay

Post-operative bleeding

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bupivacaine injectionExperimental Treatment1 Intervention

This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.

Group II: Placebo ControlPlacebo Group1 Intervention

This group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.

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