Intrathecal morphine and urinary retention after revision knee replacement
Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine
This study will see if adding a small dose of spinal (intrathecal) morphine for adults having revision knee replacement lowers early pain but raises the chance of needing a urinary catheter.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07050277 on ClinicalTrials.gov |
What this trial studies
Adults undergoing unilateral, non-infected revision total knee replacement will be assigned to spinal anesthesia with intrathecal morphine or to spinal anesthesia without intrathecal morphine. All participants will receive a standardized multimodal analgesic plan including single-shot and continuous adductor canal block (CACB) and a single-shot IPACK block, plus systemic non-opioid analgesics and rescue opioids as needed. The trial will measure rates of postoperative urinary retention (POUR) and pain scores in the immediate postoperative period. Secondary outcomes include opioid consumption, common opioid-related adverse effects (nausea, pruritus, respiratory depression), and length of hospital stay.
Who should consider this trial
Good fit: Adults older than 21 having unilateral, non-infected revision total knee arthroplasty, ASA physical status I–III, BMI under 45, without recent opioid use above the protocol threshold, and able to consent in English are ideal candidates.
Not a fit: Patients with infected revisions, recent or current high-dose opioid use, contraindications to neuraxial anesthesia or peripheral nerve blocks, pregnancy, or who cannot attend the Toronto surgical site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If positive, the results could show whether intrathecal morphine gives better early pain control after revision knee replacement while clarifying the risk of urinary retention to help tailor anesthesia choices.
How similar studies have performed: Prior studies in lower-limb and abdominal surgery have shown intrathecal morphine reduces early postoperative pain and opioid needs but is also linked to higher rates of urinary retention and opioid-related side effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non pregnant patients undergoing unilateral non infected rTKA surgery; * Older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-III; * With no alcohol or drug dependency history; * With sufficient understanding and co-operation about the usage of a perineural catheter for pain management; body mass index (BMI) under 45; * With no allergy to medications used in the study protocol (bupivacaine, lidocaine, ropivacaine, midazolam, propofol, ketamine, morphine, hydromorphone, fentanyl, acetaminophen, celecoxib, ondansetron, dexamethasone, tranexamic acid); * No current or recent use of opioids (within the last 2 weeks) in an average oral morphine equivalent (OME) of 20 mg/day or higher; * With no contra-indications for neuraxial anesthesia, IPACK block, ACB and adductor canal catheter insertion; * Who speak and understand the English language; * Who agrees to participate on this study through the signature of the consent form. Exclusion Criteria: * Patients will be excluded of the study if they have a failed spinal anesthesia and needs for a conversion to general anesthesia; * If peripheral nerve blocks are not possible to be performed due to technical difficulties; * If during patient's care a deviation of the protocol occurs; * If CACB catheter has issues on its function, disconnects or exteriorizes within the first 48 hours of infusion; * Or if patient decides to withdraw from the study.
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Hermann dos Santos Fernandes, MD, PhD — Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant
- Study coordinator: Hermann dos Santos Fernandes, MD, PhD
- Email: hermann.dossantosfernandes@sinaihealth.ca
- Phone: 416-586-5270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.