nctId: NCT06332443 id: CER-CEMTL-2023-3086 briefTitle: Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. acronym: RCT SEA vs SA overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2026-03-15 date: 2024-03-27 date: 2024-03-27 name: Maisonneuve-Rosemont Hospital class: OTHER name: Mina Wahba Morcos name: Issam Tanoubi name: Pierre Drolet name: Ariane Clairoux name: Veronique Brulotte name: Marie-Eve Bélanger name: Philippe Richebé name: Karina Pellei briefSummary: 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. conditions: Knee Injuries and Disorders conditions: Hip Injuries conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Spinal anesthesia name: Sedation epidural anesthesia measure: Adverse Events measure: Time needed by the anesthesiologist to perform the technique measure: Time needed for the SA or SED-EA to achieve adequate sensory block measure: Intraoperative blood loss measure: intraoperative muscle tension measure: Extra Lidocaine needed measure: Conversion to GA measure: Total dose of the sedation measure: Hemodynamic stability measured measure: Time to return of motor and sensory function measure: Post-operative nausea measure: PONV and anti-emetics measure: Urinary retention measure: Opioid consumption measure: Length of stay measure: Failed discharded measure: Complications related to the technique performed. measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Maisonneuve Rosemont status: RECRUITING city: Montreal state: Quebec zip: H1T 2M4 country: Canada name: Serge Marquis, RN role: CONTACT phone: 5142523400 phoneExt: 5701 email: smarquis.hmr@ssss.gouv.qc.ca name: Janie Barry, MSc role: CONTACT phone: 5142523400 phoneExt: 4567 email: jbarry.hmr@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 hasResults: False