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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Injuries; Anesthesia; Knee Injuries and Disorders
• Intervention / Treatment: Procedure: Spinal anesthesia; Procedure: Sedation epidural anesthesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serge Marquis, inf; Phone Number: 5701 514-252-3400; Email: smarquis.hmr@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve Rosemont
      • Contact: Serge Marquis, RN; Phone Number: 5701 5142523400; Email: smarquis.hmr@ssss.gouv.qc.ca
      • Contact: Janie Barry, MSc; Phone Number: 4567 5142523400; Email: jbarry.hmr@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The number of overall adverse events will be categorized according to the Clavien-Dindo classification	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed by the anesthesiologist to perform the technique	Defined as the time frame from the end of the disinfection process to the time the medication is injected in the SA group or the catheter is secure in the SED-EA group (unit: mins).	Day 0
Time needed for the SA or SED-EA to achieve adequate sensory block	defined as the time frame from the end of the anesthesia technique to the time the patient can no longer feel cold at her lower extremity.	Day 0
Intraoperative blood loss	measured from the contents of suction bottles and the increased weight of surgical swabs by the operative nurse.	Day 0
intraoperative muscle tension	rating which is rated on 4-point scale that blinded surgeons will use. The scale is as follows: 0 = most relaxed; 1 = mildly tight; 2 = moderately tight; and 3 = very tight.	Day 0
Extra Lidocaine needed	An extra 5 mL of lidocaine 2% will be administrated through the SED-EA catheter if muscle tension or analgesia is judged not optimal by the surgeon and/or anesthesiologist. Need for dose adjustment of the SED-EA intraoperatively will be recorded by the anesthetist.	Day 0
Conversion to GA	If muscle tension and/or analgesia is still deemed suboptimal with extra lidocaine in SED-EA of after a SA, conversion to GA will be accomplished using propofol, remifentanil and a neuromuscular blocking agent. No IV opioids will be used. Anesthesia maintenance will be performed with TIVA. Rate of conversion to GA will be recorded by research personnel.	Day 0
Total dose of the sedation	Propofol sedation will be adjusted to keep a BIS index value in between 60 and 80.	Day 0
Hemodynamic stability measured	All hemodynamic parameters will be recorded by a computer hooked onto the anesthesia monitors. A mean arterial pressure (MAP) of 70 mmHg or higher will be kept with phenylephrine in 100 mcg increments (if heart rate (HR) of 50/minute and over) or ephedrine in 5 mg increments (if HR under 50). Total doses of vasopressors used will be recorded.	Day 0
Time to return of motor and sensory function	time to return of motor function is defined as the time when muscle strength in all three muscle groups tested is 5 of 5 on a 0 to 5 scale. The sensory dermatome level will be assessed using ice at the time of motor function return. Both assessments will begin 30 minutes after PACU arrival and continue every 30 minutes until motor function returns.	Day 1
Post-operative nausea	Post-operative nausea and vomiting (PONV), dizziness and confusion will be recorded by the PACU nurse using Aldrete scores.	Day 1
PONV and anti-emetics	PONV and anti-emetics in day care unit will be recorded.	Day 1
Urinary retention	Urinary retention, defined by the inability to urinate for 8 hours after surgery or the need for a placement of a straight catheter or foley, consistent with a previous study.	Day 1
Opioid consumption	Opioid consumption will be collected by the research team.	Day 2
Length of stay	Defined as the time frame from the end of the THA/TKA surgery to the time of the discharge order.	Day 2
Failed discharded	Defined as patient who is unable to be discharged within 24 hours after the end of surgery.	Day 2
Complications related to the technique performed.	Complications related to the technique performed.	Day 3
Adverse event	Adverse event	Day 3

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Collaborators: Issam Tanoubi; Mina Wahba Morcos; Pierre Drolet; Ariane Clairoux; Veronique Brulotte; Marie-Eve Bélanger; Philippe Richebé; Karina Pellei
• Investigators: Principal Investigator: Mina Morcos, Dr, Ciusss de L'Est de l'Île de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Hip Injuries; Knee Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CER-CEMTL-2023-3086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No