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Clinical Trials in Canada / NCT07050277
Recruiting Phase 3

Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine

NCT07050277 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-06-24
Last updated
2025-12-29

Condition(s) studied

Arthroplasties, Knee ReplacementNerve BlockUrinary Retention PostoperativeAnesthesia, Spinal

Investigational drug(s) / intervention(s)

Intrathecal Morphine →No Intrathecal Morphine

Intrathecal Morphine: Intrathecal morphine

No Intrathecal Morphine: No Intrathecal Morphine

Study 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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mount Sinai Hospital Toronto Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07050277 on ClinicalTrials.gov ↗ ← All trials in Canada