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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Hermann dos Santos Fernandes, MD, PhD
hermann.dossantosfernandes@sinaihealth.ca
416-586-5270
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Intrathecal Morphine
Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg + Morphine 100 mcg
Experimental: No Intrathecal Morphine
Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg
Related Therapeutic Areas
Sponsors
Leads: University of Toronto

This content was sourced from clinicaltrials.gov