Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spina… (NCT06332443) | Clinical Trial Compass
UnknownNot Applicable
Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.
Canada132 participantsStarted 2023-03-15
Plain-language summary
To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient has symptomatic hip or knee OA requiring primary joint replacement (not associated with unusual treatments such as bone graft, concomitant osteotomy, revision implant, etc.).
* Patient who is candidate for our ERAS program
* Patient understands the study condition
* Patient capable of giving informed consent.
* Someone to accompany the patient to the Pre-admission Clinic and hospital the day of the surgery and to be available in the first postoperative week during home recovery.
Exclusion Criteria:
* Patients with contraindication to NA (spinal anatomical abnormalities, coagulation disorders, infection at the puncture site)
* Allergy to LAs used in the study
* Unable to communicate with the investigators, unable to read the questionnaire, unable to keep track and notes of the medication taken at home
* Lack of home services offered by the local community service centre in the area.
* BMI \> 40.
* Psychiatric disease limiting participation or interfering with the ability to provide consent or assessment
* Need for long-term urinary Foley catheter post-op.
* Allergies to sulfonamides or other medications specified in the protocol.
* Cognitive impairment or communication problem
* Pulmonary embolism or deep vein thrombosis in the past year.
* Need for long-term anticoagulation therapy.
* Current corticotherapy or systemic corticotherapy in the past year (unless confirmation of a cortrosyn test prior to surgery).
* Systemic disease involvement (di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.