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

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.

Conditions

• Knee Injuries and Disorders
• Hip Injuries
• Anesthesia

Interventions

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.

Sponsors & Collaborators

• Mina Wahba Morcos

  collaborator UNKNOWN

• Issam Tanoubi

  collaborator UNKNOWN

• Pierre Drolet

  collaborator UNKNOWN

• Ariane Clairoux

  collaborator UNKNOWN

• Veronique Brulotte

  collaborator UNKNOWN

• Marie-Eve Bélanger

  collaborator UNKNOWN

• Philippe Richebé

  collaborator UNKNOWN

• Karina Pellei

  collaborator UNKNOWN

• Maisonneuve-Rosemont Hospital

  lead OTHER

Principal Investigators

• Mina Morcos, Dr · Ciusss de L'Est de l'Île de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-15

Primary Completion

2025-03-15

Completion

2026-03-15

Countries

• Canada

Study Locations