Intrathecal morphine and urinary retention after revision knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.