protocolSection identificationModule nctId: NCT06332443, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Maisonneuve-Rosemont Hospital, class: OTHER, collaborators name: Mina Wahba Morcos, collaborators name: Issam Tanoubi, collaborators name: Pierre Drolet, collaborators name: Ariane Clairoux, collaborators name: Veronique Brulotte, collaborators name: Marie-Eve Bélanger, collaborators name: Philippe Richebé, collaborators name: Karina Pellei, descriptionModule 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., conditionsModule conditions: Knee Injuries and Disorders, conditions: Hip Injuries, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Spinal anesthesia, interventions name: Sedation epidural anesthesia, outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Time needed by the anesthesiologist to perform the technique, secondaryOutcomes measure: Time needed for the SA or SED-EA to achieve adequate sensory block, secondaryOutcomes measure: Intraoperative blood loss, secondaryOutcomes measure: intraoperative muscle tension, secondaryOutcomes measure: Extra Lidocaine needed, secondaryOutcomes measure: Conversion to GA, secondaryOutcomes measure: Total dose of the sedation, secondaryOutcomes measure: Hemodynamic stability measured, secondaryOutcomes measure: Time to return of motor and sensory function, secondaryOutcomes measure: Post-operative nausea, secondaryOutcomes measure: PONV and anti-emetics, secondaryOutcomes measure: Urinary retention, secondaryOutcomes measure: Opioid consumption, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Failed discharded, secondaryOutcomes measure: Complications related to the technique performed., secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Maisonneuve Rosemont, status: RECRUITING, city: Montreal, state: Quebec, zip: H1T 2M4, country: Canada, contacts name: Serge Marquis, RN, role: CONTACT, phone: 5142523400, phoneExt: 5701, email: smarquis.hmr@ssss.gouv.qc.ca, contacts name: Janie Barry, MSc, role: CONTACT, phone: 5142523400, phoneExt: 4567, email: jbarry.hmr@ssss.gouv.qc.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False