Comparing sedation-epidural anesthesia and spinal anesthesia for outpatient hip or knee surgery
Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.
This study is testing whether sedation-epidural anesthesia or spinal anesthesia is better for patients having outpatient hip or knee surgery by looking at complications and recovery outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Maisonneuve-Rosemont Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06332443 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of sedation-epidural anesthesia (SED-EA) versus spinal anesthesia (SA) in patients undergoing outpatient hip or knee arthroplasty. The primary objective is to assess the overall complication rate within 72 hours post-surgery, categorized by the Clavien-Dindo classification. Secondary objectives include evaluating perioperative and postoperative events such as pain levels, opioid consumption, time to mobilization, and hospital length of stay. The findings could enhance the established Enhanced Recovery After Surgery (ERAS) program by identifying the most effective anesthesia technique for these procedures.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic hip or knee osteoarthritis requiring primary joint replacement who are eligible for the ERAS program.
Not a fit: Patients with contraindications to neuraxial anesthesia, severe obesity (BMI > 40), or psychiatric conditions that limit participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and faster recovery for patients undergoing hip or knee arthroplasty.
How similar studies have performed: While this specific comparison has not been extensively studied, similar approaches in anesthesia techniques have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Mina Morcos, Dr — Ciusss de L'Est de l'Île de Montréal
- Study coordinator: Serge Marquis, inf
- Email: smarquis.hmr@ssss.gouv.qc.ca
- Phone: 514-252-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.