Intrathecal Morphine for Urinary Retention

(POURRKA Trial)

Overseen By Hermann dos Santos Fernandes, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Toronto

Must not be taking: Opioids

Disqualifiers: Failed spinal anesthesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intrathecal morphine (a pain-relief drug administered in the spine) affects urinary retention and pain following knee surgery. Researchers compare two groups: one receiving morphine and one not, to determine if pain control is similar and if the group without morphine experiences fewer urination issues. Participants should be undergoing revision total knee arthroplasty (rTKA) without infection and must be comfortable using a catheter for pain management. The study aims to enhance recovery experiences for patients after knee surgery. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for knee surgery recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids at a certain level in the last two weeks. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that administering morphine directly into the spinal fluid, known as intrathecal morphine, can reduce pain after surgery. However, it can also cause side effects. Studies have found that it may lead to nausea, vomiting, itching, and urinary retention. In one study, about 42% of participants experienced mild urinary retention, but this usually didn't require medical treatment.

Another study found no major issues with urinary retention or serious breathing problems linked to intrathecal morphine. This suggests that while side effects like nausea and itching are more common, serious problems are less likely. Overall, intrathecal morphine is generally well-tolerated, but it does carry some risks to consider for those thinking about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using intrathecal morphine for urinary retention because it introduces morphine directly into the spinal fluid, potentially offering targeted pain relief while minimizing systemic side effects. Unlike standard treatments that may rely on oral pain medications, this method could provide more effective pain control specifically at the site of surgery or injury. Additionally, by enhancing the pain relief of spinal anesthesia with the addition of morphine, there is potential for improved patient comfort and reduced need for additional opioids post-surgery.

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

Research has shown that using morphine in the spine effectively reduces pain after surgery. Studies have found that it significantly lowers pain levels when included in anesthesia. However, it can cause side effects. Difficulty urinating is common, with some studies estimating it occurs in about 42% of cases. Other frequently reported side effects include nausea, vomiting, and itching. In this trial, some participants will receive intrathecal morphine, while others will not, allowing for a comparison of these effects. Despite these concerns, its pain management capability makes it a commonly considered option. ^{1 2 3 4 5}

Who Is on the Research Team?

Hermann dos Santos Fernandes, MD, PhD

Principal Investigator

Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant

Are You a Good Fit for This Trial?

This trial is for patients undergoing revision knee replacement surgery who will receive spinal anesthesia. They're looking at how using intrathecal morphine affects post-surgery urinary retention and pain. To join, participants must be eligible for the surgery and anesthesia.

Inclusion Criteria

Speak and understand the English language

Agrees to participate in this study through the signature of the consent form

No alcohol or drug dependency history

Exclusion Criteria

Deviation from the protocol during patient's care

CACB catheter malfunction within the first 48 hours of infusion

My spinal anesthesia did not work, requiring a switch to general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Operative Management

Participants receive preoperative analgesic medication and undergo nerve blocks

1 day

1 visit (in-person)

Surgery and Immediate Post-Operative Care

Participants undergo revision knee arthroplasty and receive spinal anesthesia with or without intrathecal morphine

1 day

1 visit (in-person)

Post-Operative Monitoring

Participants are monitored for pain, urinary retention, and recovery quality

48 hours

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Phone assessment and in-person if needed

What Are the Treatments Tested in This Trial?

Interventions

• Intrathecal Morphine
• No Intrathecal Morphine

Trial Overview The study compares two groups: one receiving intrathecal morphine during spinal anesthesia for knee surgery, and another not receiving it. Both groups get nerve blocks to manage pain. The goal is to see if avoiding morphine reduces urinary issues without increasing pain.

How Is the Trial Designed?

Group I: No Intrathecal Morphine Experimental Treatment 1 Intervention

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg

Group II: Intrathecal Morphine Active Control 1 Intervention

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg + Morphine 100 mcg

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224004161

Non-pulmonary complications of intrathecal morphine ... Intrathecal morphine significantly increased postoperative nausea and vomiting, pruritus, and urinary retention after surgery or labour in a dose-independent ...

2. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2008.05817.x

Risks and side‐effects of intrathecal morphine combined with ... Intrathecal morphine results in a moderate and clinically relevant increase in nausea, vomiting, pruritus and urinary retention in our meta-analysis.

3. digitalscholar.lsuhsc.edu digitalscholar.lsuhsc.edu/som_facpubs/2819/

"Efficacy and Safety of Intrathecal Morphine for Cesarean ... Commonly observed side effects of intrathecal opioids include nausea, vomiting, pruritus, and urinary retention, and it is thought that the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214442021003752

Severe urinary retention secondary to intrathecal morphine ... Mild urinary retention, not requiring intervention, following intrathecal morphine administration has an estimated incidence of approximately 42% in ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK76659/

Risks and side-effects of intrathecal morphine combined with ... There were no statistically significant changes in urinary retention or respiratory depression after treatment with intrathecal morphine.