New treatment option for Arthroplasties, Knee Replacement
Official title Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine
ClinicalTrials.gov ID: NCT07050277
What this study is testing
What is Intrathecal Morphine?
Intrathecal Morphine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for arthroplasties, knee replacement.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.