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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
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 moreAwards & 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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Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
339,877 Total Patients Enrolled
1 Trials studying Postoperative Pain
103 Patients Enrolled for Postoperative Pain
Dr. Kesava Reddy, MDPrincipal InvestigatorHamilton Health Sciences Corporatin