Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.

Launched by MAISONNEUVE-ROSEMONT HOSPITAL · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of anesthesia—sedation combined with epidural anesthesia (SED-EA) and spinal anesthesia (SA)—to see which one works better for patients undergoing hip or knee replacement surgery. The goal is to understand how these anesthesia methods might affect recovery, especially in terms of pain control and how quickly patients can get moving after surgery. By comparing these techniques, the researchers hope to improve care for patients participating in an Enhanced Recovery After Surgery (ERAS) program.

To be eligible for this trial, participants should be between 65 and 74 years old and have symptoms of arthritis in their hip or knee that require surgery. They need to be able to understand the study and provide consent, and have someone to assist them during their hospital visit and recovery. However, people with certain health issues or complications, such as severe allergies, significant weight issues, or other serious medical conditions, will not be able to participate. If you join the study, you’ll receive one of the two anesthesia types before your surgery, and the team will monitor your recovery closely to see how well you do.

Gender

ALL

Eligibility criteria

• 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 (diabetes, heart, kidney, blood, etc.) necessitating special perioperative care (intensive care, multiple transfusions, dialysis, etc.).
• • Coagulation disorder increasing the risk of intraoperative and postoperative bleeding including thrombocytopenia (platelet count lower than 80), hemophilia, prolonged INR (1,4 and over) and any order coagulation disorder deemed a contra-indication to neuraxial anesthesia..
• • Locomotor problem, other than the joint to be replaced, imposing functional limitations that prevent movement without technical or physical assistance.
• • Neurological or balance disorder.
• • Living space incompatible with home care.
• • Clcr \< 30 ml/min (Cockcroft-Gault formula).
• • Pregnancy