NCT06332443

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective is to compare the overall complication rate within 72 hours after surgery, categorized according to the Clavien-Dindo classification (15), between both techniques following THA and TKA surgery. Secondary objectives are to compare the following perioperative and postoperative events between both groups: 1. Perioperative 1. Preoperative pain levels and opioid/analgesics consumption 2. Time needed to perform the technique (from the first handling the needle to sterile drapes removal from the back of the patient) 3. Time needed for the SA or SED-EA to achieve adequate sensory block (from LA injection to the absence of cold feeling at T8 allowing surgical incision 4. Intraoperative blood loss 5. Need for dose adjustment intraoperatively 6. Hemodynamic instability defined by hypotension (-20% from basal values prior to entering the OR, at the time of the consent). 2. Post-operative 1. Time to motor and sensory function return 2. Time to mobilization 3. Pain evaluated with Visual analog scale immediately after surgery and up to 72 hours after surgery 4. Opioid consumption up to 48 hours 5. Hospital LOS and incidence of failed discharge at planned time 6. Complications related to the technique performed (Post-dural puncture headache, local infection, hematoma etc.) HYPOTHESIS We hypothesize that the incidence of the overall complication rate within 3 days after surgery, categorized according to the Clavien-Dindo classification will be equivalent between both groups; SED-EA and SA.

Conditions

• Knee Injuries and Disorders
• Hip Injuries
• Anesthesia

Interventions

Type	Name	Description
PROCEDURE	Spinal anesthesia	Spinal anesthesia 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.
PROCEDURE	Sedation epidural anesthesia	Sedation-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.

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-03-15
• Completion: 2026-03-15
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: Canada