Nerve Block for Postoperative Pain

(POPPY Trial)

Overseen By Ms. Jessy Moore, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hamilton Health Sciences Corporation

Must not be taking: Antidepressants, Benzodiazepines, Gabapentin, Opioids

Disqualifiers: Chronic pain, Alcohol abuse, Hypertension, Kidney or liver diseases, Cardiomyopathies, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.

Who Is on the Research Team?

Dr. Kesava Reddy, MD

Principal Investigator

Hamilton Health Sciences Corporatin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an adult having surgery for a pituitary tumor through my nose.

Exclusion Criteria

I am on medication for chronic pain, including antidepressants or opioids.

I do not have severe kidney or liver diseases.

Chronic alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo minimally invasive pituitary surgery with either bupivacaine injection, placebo injection, or no injection for pain management

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants' pain levels and post-operative complications are monitored at multiple time points within the first 24 hours after surgery

1 day

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-operative bleeding, length of stay, and analgesic requirements

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Sphenopalatine Ganglion Block

Trial Overview 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.

How Is the Trial Designed?

Group I: Bupivacaine injection Experimental Treatment 1 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 Control Placebo Group 1 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.

Group III: Sham - no injection Placebo Group 1 Intervention

Participants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+