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

Anesthesia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anesthesia
• Hip Injuries
• Knee Injuries
• Knee Injuries and Disorders
• Wounds and Injuries

• NCT number: NCT06332443
• Study type: Interventional
• Source: Maisonneuve-Rosemont Hospital
• Contact: Serge Marquis, inf
• Phone: 514-252-3400
• Email: smarquis.hmr@ssss.gouv.qc.ca
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Completion date: March 15, 2026