Recruiting

Epidural Anesthesia vs. Spinal Anesthesia

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT06332443

Conditions

Knee Injuries and Disorders

Hip Injuries

Anesthesia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal anesthesia

Sedation epidural anesthesia

Study Details

Brief 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

Study ID

NCT06332443

Start date

Mar 15, 2023

Status verified date

Mar, 2024

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Mar 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Adverse Events [ Time Frame: Day 3 ]

Central Contacts and Locations

Central contacts

Serge Marquis, inf

514-252-3400smarquis.hmr@ssss.gouv.qc.ca

Locations

Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Serge Marquis, RN

5142523400smarquis.hmr@ssss.gouv.qc.ca

Janie Barry, MSc

5142523400jbarry.hmr@ssss.gouv.qc.ca

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Mar 27, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2024-03-27.