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

NCT07050277 | Recruiting Phase 3

• 1 other identifier: MSH REB # 0065
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative urinary retention

  need of bladder catheterization at any moment

  First 48 hours after spinal anesthesia

Secondary Outcomes (4)

• Quality of Recovery

  24 and 48 hours after spinal anesthesia

• Pain at rest

  24 and 48 hours after spinal anesthesia

• Pain at movement

  24 and 48 hours after spinal anesthesia

• Opioid consumption

  24 and 48 hours after spinal anesthesia

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg + Morphine 100 mcg

Drug: Intrathecal Morphine

No Intrathecal Morphine

EXPERIMENTAL

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg

Drug: No Intrathecal Morphine

Interventions

Intrathecal Morphine DRUG

Intrathecal morphine

Intrathecal Morphine

No Intrathecal Morphine DRUG

No Intrathecal Morphine

No Intrathecal Morphine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (11)

• Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.

  PMID: 35852550 BACKGROUND

• Dana E, Ben-Zur O, Dichtwald S, Feigin G, Brin N, Markushevich M, Fredman B, Brin YS. Postoperative urinary retention following hip or knee arthroplasty under spinal anaesthesia with intrathecal morphine: a retrospective cohort study. Singapore Med J. 2025 Sep 1;66(9):481-485. doi: 10.4103/singaporemedj.SMJ-2022-108. Epub 2023 Jun 13.

  PMID: 37338499 BACKGROUND

• Scholten R, Kremers K, van de Groes SAW, Somford DM, Koeter S. Incidence and Risk Factors of Postoperative Urinary Retention and Bladder Catheterization in Patients Undergoing Fast-Track Total Joint Arthroplasty: A Prospective Observational Study on 371 Patients. J Arthroplasty. 2018 May;33(5):1546-1551. doi: 10.1016/j.arth.2017.12.001. Epub 2017 Dec 13.

  PMID: 29306574 BACKGROUND

• Staikou C, Paraskeva A. The effects of intrathecal and systemic adjuvants on subarachnoid block. Minerva Anestesiol. 2014 Jan;80(1):96-112. Epub 2013 Jul 9.

  PMID: 23839318 BACKGROUND

• Tomaszewski D, Balkota M, Truszczynski A, Machowicz A. Intrathecal morphine increases the incidence of urinary retention in orthopaedic patients under spinal anaesthesia. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):29-33. doi: 10.5603/AIT.2014.0006.

  PMID: 24643924 BACKGROUND

• Cha YH, Lee YK, Won SH, Park JW, Ha YC, Koo KH. Urinary retention after total joint arthroplasty of hip and knee: Systematic review. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(1):2309499020905134. doi: 10.1177/2309499020905134.

  PMID: 32114894 BACKGROUND

• Garbarino LJ, Gold PA, Anis HK, Sodhi N, Danoff JR, Boraiah S, Rasquinha VJ, Mont MA. Does Intermittent Catheterization Compared to Indwelling Catheterization Decrease the Risk of Periprosthetic Joint Infection Following Total Knee Arthroplasty? J Arthroplasty. 2020 Jun;35(6S):S308-S312. doi: 10.1016/j.arth.2020.02.055. Epub 2020 Feb 28.

  PMID: 32192833 BACKGROUND

• Janiak M, Kowalczyk R, Gorniewski G, Olczyk-Miiller K, Kowalski M, Nowakowski P, Trzebicki J. Efficacy and Side Effect Profile of Intrathecal Morphine versus Distal Femoral Triangle Nerve Block for Analgesia following Total Knee Arthroplasty: A Randomized Trial. J Clin Med. 2022 Nov 25;11(23):6945. doi: 10.3390/jcm11236945.

  PMID: 36498519 BACKGROUND

• Li XM, Huang CM, Zhong CF. Intrathecal morphine verse femoral nerve block for pain control in total knee arthroplasty: A meta-analysis from randomized control trials. Int J Surg. 2016 Aug;32:89-98. doi: 10.1016/j.ijsu.2016.06.043. Epub 2016 Jul 6.

  PMID: 27370542 BACKGROUND

• Grant AE, Schwenk ES, Torjman MC, Hillesheim R, Chen AF. Postoperative Analgesia in Patients Undergoing Primary or Revision Knee Arthroplasty with Adductor Canal Block. Anesth Pain Med. 2017 Apr 17;7(3):e46695. doi: 10.5812/aapm.46695. eCollection 2017 Jun.

  PMID: 28824869 BACKGROUND

• Dos Santos Fernandes H, Siddiqui N, Peacock S, Vidal E, Wolfstadt J, Gleicher Y. Inter-fascial space between SArtorius muscle and FEmoral artery (ISAFE): A suggested approach for Adductor Canal catheter placement. J Clin Anesth. 2022 Feb;76:110571. doi: 10.1016/j.jclinane.2021.110571. Epub 2021 Nov 8. No abstract available.

  PMID: 34763273 BACKGROUND

Study Officials

• Hermann dos Santos Fernandes, MD, PhD

  Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermann dos Santos Fernandes, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CA (1)