Recruiting
Phase 3

Spinal Anesthesia with IM vs. No IM

Sponsor:

University of Toronto

Code:

NCT07050277

Conditions

Arthroplasties, Knee Replacement

Nerve Block

Urinary Retention Postoperative

Anesthesia, Spinal

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Intrathecal Morphine

No Intrathecal Morphine

Study Details

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.

Conditions

Arthroplasties, Knee Replacement

Nerve Block

Urinary Retention Postoperative

Anesthesia, Spinal

Study ID

NCT07050277

Start date

Jun 24, 2025

Status verified date

Dec, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Intrathecal Morphine

Intrathecal morphine

No Intrathecal Morphine

No Intrathecal Morphine

Primary outcome measure

  • Postoperative urinary retention [ Time Frame: First 48 hours after spinal anesthesia ]

Central Contacts and Locations

Central contacts

Hermann dos Santos Fernandes, MD, PhD

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

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Hermann dos Santos Fernandes, MD, PhD

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

More Information

Sponsor

University of Toronto

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-12-29.