RecruitingPhase 3

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

Canada50 participantsStarted 2025-06-24

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative urinary retention

Timeframe: First 48 hours after spinal anesthesia

Trial details

NCT IDNCT07050277

SponsorUniversity of Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Hermann dos Santos Fernandes, MD, PhD

416-586-5270 hermann.dossantosfernandes@sinaihealth.ca

View on ClinicalTrials.gov More Arthroplasties, Knee Replacement trials