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

NCT06332443 | Recruiting DMC

• 1 other identifier: CER-CEMTL-2023-3086
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  The number of overall adverse events will be categorized according to the Clavien-Dindo classification

  Day 3

Secondary Outcomes (17)

• Time needed by the anesthesiologist to perform the technique

  Day 0

• Time needed for the SA or SED-EA to achieve adequate sensory block

  Day 0

• Intraoperative blood loss

  Day 0

• intraoperative muscle tension

  Day 0

• Extra Lidocaine needed

  Day 0

Study Arms (2)

SA

ACTIVE COMPARATOR

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)

Procedure: Spinal anesthesia

SED-EA

ACTIVE COMPARATOR

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.

Procedure: Sedation epidural anesthesia

Interventions

Spinal anesthesia PROCEDURE

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.

SA

Sedation epidural anesthesia PROCEDURE

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.

SED-EA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Mina Wahba Morcos: collaborator
• Issam Tanoubi: collaborator
• Pierre Drolet: collaborator
• Ariane Clairoux: collaborator
• Veronique Brulotte: collaborator
• Marie-Eve Bélanger: collaborator
• Philippe Richebé: collaborator
• Karina Pellei: collaborator

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Disease; Hip Injuries

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mina Morcos, Dr

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge Marquis, inf

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedist

Model Details: This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 27, 2024
• Study Start: March 15, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

CA (1)