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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Hopital Maisonneuve Rosemont
RECRUITING
Montreal
Contact Information
Primary
Serge Marquis, inf
smarquis.hmr@ssss.gouv.qc.ca
514-252-3400
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 132
Treatments
Active_comparator: SA
SA will be performed in the sitting or lateral position under sterile conditions. Spinal puncture will be performed at L2-L4 level using 50 mg of Clorotekal 1 or 2%. (intermediate-acting amide local anesthesia, commonly used) will be injected (32-34)
Active_comparator: SED-EA
EA will be performed in the sitting or lateral position under sterile conditions. Epidural puncture will be performed at the L2-L4 level and an epidural catheter will be inserted into the epidural space. 10 ml of 2% xylocaine without epinephrine will be injected through the catheter and the dose will be titrated (up to 20 mL) to achieve complete sensory block up to T12 dermatoma measured with a level to ice.
Sponsors
Collaborators: Marie-Eve Bélanger, Ariane Clairoux, Issam Tanoubi, Mina Wahba Morcos, Karina Pellei, Veronique Brulotte, Philippe Richebé, Pierre Drolet
Leads: Maisonneuve-Rosemont Hospital

This content was sourced from clinicaltrials.gov