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?

This trial aims to determine if an extra nerve block, specifically a Sphenopalatine Ganglion Block, can better manage pain after minimally invasive pituitary surgery. Participants will receive either a Bupivacaine injection, a placebo (saltwater) injection, or no extra injection. The researchers aim to assess whether this method reduces pain and the need for pain medication post-surgery. Suitable candidates have undergone endonasal pituitary surgery but do not have chronic pain conditions requiring certain medications or severe heart, liver, or kidney issues. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications for chronic pain, like antidepressants, benzodiazepines, gabapentin, or opioids.

What is the safety track record for the Sphenopalatine Ganglion Block treatment?

Research has shown that using bupivacaine for a sphenopalatine ganglion block is generally safe. Studies have found that this treatment effectively reduces pain after surgery. Most patients tolerate it well, with few serious side effects reported. Some common side effects include headaches or swelling, but these are rare. The treatment's approval for other uses supports its safety. Overall, bupivacaine is considered a reliable option for easing post-surgical pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the potential of the sphenopalatine ganglion block using bupivacaine for postoperative pain relief because it offers a targeted approach that differs from standard pain management methods. Unlike traditional treatments that often involve systemic opioids or oral analgesics, this technique involves a direct injection into a specific nerve cluster, potentially reducing systemic side effects. Bupivacaine acts as a local anesthetic, providing prolonged pain relief with its unique mechanism of action, which could enhance recovery and comfort after surgery. Furthermore, the addition of epinephrine helps to prolong the effects of bupivacaine, making this method potentially more effective than existing options.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that a sphenopalatine ganglion block with bupivacaine can help manage post-surgical pain. In this trial, one group will receive a bupivacaine injection, another group will receive a placebo injection, and a third group will undergo a sham procedure without an injection. Several studies have found that patients who received bupivacaine experienced less pain after their operations compared to those who received a placebo. Specifically, one study found that this method led to better pain control and reduced the need for other pain medications. Another study discovered that bupivacaine not only helped with pain but also improved conditions in the surgical area. Overall, the evidence supports bupivacaine as an effective option for reducing post-surgical pain. ^{1 2 4 5 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6348495/

Effect of Sphenopalatine Ganglion Block With Bupivacaine ... They suggest that postoperative pain in patients undergoing the ganglion block might be reduced with general anesthesia compared to a placebo ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30719401/

Effect of Sphenopalatine Ganglion Block With Bupivacaine ... Conclusion: SPGB with bupivacaine 0.5% (1.5 mL) was a simple, effective, safe, and noninvasive method for the management of postoperative pain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06847425?term=AREA%5BConditionSearch%5D(%22Mucinoses%22)&rank=6

Sphenopalatine Ganglion Block with Bupivacaine and Its ... This study aims to explore the influence of sphenopalatine ganglion block on pain intensity after functional endoscopic sinus surgery by comparing two groups, ...

4. apicareonline.com apicareonline.com/index.php/APIC/article/view/2820/4285

View of The effect of sphenopalatine ganglion block with 0.5 ... Conclusions: Sphenopalatine ganglion block using 0.5% bupivacaine results in better postoperative pain management, and a reduced need for analgesics in ...

5. ejo.springeropen.com ejo.springeropen.com/articles/10.1186/s43163-023-00481-5

Bupivacaine improves surgical field and postoperative pain ... Sphenopalatine ganglion block was found effective in reducing the postoperative pain as compared to placebo. Sphenopalatine ganglion block was ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1808869423001416

Postoperative effects of bilateral sphenopalatine ganglion ... Sphenopalatine ganglion blockade was very effective in postoperative pain control after septorhinoplasty operations. •. Sphenopalatine ganglion blockade ...