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| Name | Class |
|---|---|
| Mina Wahba Morcos | UNKNOWN |
| Issam Tanoubi | UNKNOWN |
| Pierre Drolet | UNKNOWN |
| Ariane Clairoux |
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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.
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:
Perioperative
Post-operative
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The number of overall adverse events will be categorized according to the Clavien-Dindo classification | Day 3 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serge Marquis, inf | Contact | 514-252-3400 | 5701 | smarquis.hmr@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mina Morcos, Dr | Ciusss de L'Est de l'Île de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Maisonneuve Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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| Veronique Brulotte | UNKNOWN |
| Marie-Eve Bélanger | UNKNOWN |
| Philippe Richebé | UNKNOWN |
| Karina Pellei | UNKNOWN |
This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group
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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.
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| 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. |
|
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 |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D004194 | Disease |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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