Nerve Block for Postoperative Pain
(POPPY Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDr. Kesava Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Hamilton Health Sciences Corporation

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

See 3 more

Trial Timeline

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

Treatment Details

Interventions

Sphenopalatine Ganglion Block (Local Anesthetic)

Trial OverviewThe 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.

Participant Groups

3Treatment 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.

Group III: Sham - no injectionPlacebo Group1 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.