NCT07050277 Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine
| NCT ID | NCT07050277 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Toronto |
| Condition | Arthroplasties, Knee Replacement |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2025-06-24 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Revision total knee arthroplasty (rTKA) is a frequently performed procedure. Adequate pain management is an important feature, especially for fast-track and Enhanced Recovery After Surgery (ERAS) programs. The multimodal approach, including single shot or continuous nerve blocks with catheters and spinal or epidural morphine, is a stablished strategy. Although the administration of intrathecal morphine (IM) has been shown to significantly reduce pain scores, it is not free of adverse effects. Postoperative urinary retention (POUR) is possible and might increase the risk of periprosthetic infection. The purpose of this study is to compare patients undergoing rTKAS under spinal anesthesia with IM to patients undergoing the same procedure, under the same anesthetic technique, but with no IM, for POUR and postoperative pain related outcomes. All patients will have single shot and continuous adductor canal block (CACB) and single shot IPACK (interspace between the popliteal artery and the posterior knee capsule) block. The hypothesis is that postoperative pain control is comparable between the groups, with lower incidence of POUR in patients with no IM given.
Eligibility 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.
Contact & Investigator
Hermann dos Santos Fernandes, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant
Frequently Asked Questions
Who can join the NCT07050277 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Arthroplasties, Knee Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07050277 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT07050277 currently recruiting?
Yes, NCT07050277 is actively recruiting participants. Contact the research team at hermann.dossantosfernandes@sinaihealth.ca for enrollment information.
Where is the NCT07050277 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07050277 clinical trial?
NCT07050277 is sponsored by University of Toronto. The principal investigator is Hermann dos Santos Fernandes, MD, PhD at Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant. The trial plans to enroll 50 participants.