Knee Injuries and DisordersRCT SEA vs SANCT06332443
Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.
A study testing Spinal anesthesia and Sedation epidural anesthesia in people with Knee Injuries and Disorders and Hip Injuries, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Injuries and Disorders, Hip Injuries, Anesthesia
- What is being tested?
- Spinal anesthesia and Sedation epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2023to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Serge Marquis, RN, 5142523400 ext. 5701, smarquis.hmr@ssss.gouv.qc.ca
Janie Barry, MSc, 5142523400 ext. 4567, jbarry.hmr@ssss.gouv.qc.ca
About this study
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.
Read the 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:
- Perioperative
- Preoperative pain levels and opioid/analgesics consumption
- Time needed to perform the technique (from the first handling the needle to sterile drapes removal from the back of the patient)
- 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
- Intraoperative blood loss
- Need for dose adjustment intraoperatively
- Hemodynamic instability defined by hypotension (-20% from basal values prior to entering the OR, at the time of the consent).
- Post-operative
- Time to motor and sensory function return
- Time to mobilization
- Pain evaluated with Visual analog scale immediately after surgery and up to 72 hours after surgery
- Opioid consumption up to 48 hours
- Hospital LOS and incidence of failed discharge at planned time
- 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.
- Conditions
- Knee Injuries and Disorders, Hip Injuries, Anesthesia
- Being tested
- Spinal anesthesia, Sedation epidural anesthesia
- Medical subject headings
- Knee Injuries, Disease, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
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 anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Procedure: Sedation epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of overall adverse events will be categorized according to the Clavien-Dindo classification
Measured: Day 3
Secondary outcomes (17)
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).
Measured: 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.
Measured: Day 0
Intraoperative blood loss
measured from the contents of suction bottles and the increased weight of surgical swabs by the operative nurse.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Total dose of the sedation
Propofol sedation will be adjusted to keep a BIS index value in between 60 and 80.
Measured: 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.
Measured: 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.
Measured: Day 1
Post-operative nausea
Post-operative nausea and vomiting (PONV), dizziness and confusion will be recorded by the PACU nurse using Aldrete scores.
Measured: Day 1
PONV and anti-emetics
PONV and anti-emetics in day care unit will be recorded.
Measured: 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.
Measured: Day 1
Opioid consumption
Opioid consumption will be collected by the research team.
Measured: 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.
Measured: Day 2
Failed discharded
Defined as patient who is unable to be discharged within 24 hours after the end of surgery.
Measured: Day 2
Complications related to the technique performed.
Complications related to the technique performed.
Measured: Day 3
Adverse event
Adverse event
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Mar 2023
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mina Wahba Morcos, Issam Tanoubi, Pierre Drolet, Ariane Clairoux, Veronique Brulotte, Marie-Eve Bélanger, Philippe Richebé, Karina Pellei
- Responsible party
- Principal investigator, Pascal André Vendittoli, Maisonneuve-Rosemont Hospital
- Investigators
- Mina Morcos, Dr, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332443
- Sponsor's protocol ID
- CER-CEMTL-2023-3086
- Acronym
- RCT SEA vs SA
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT06332443
- Acronym / sponsor ID
- RCT SEA vs SA / CER-CEMTL-2023-3086
- Conditions
- Knee Injuries and Disorders, Hip Injuries, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Mina Wahba Morcos, Issam Tanoubi, Pierre Drolet, Ariane Clairoux, Veronique Brulotte, Marie-Eve Bélanger, Philippe Richebé, Karina Pellei
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Perioperative
- Preoperative pain levels and opioid/analgesics consumption
- Time needed to perform the technique (from the first handling the needle to sterile drapes removal from the back of the patient)
- 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
- Intraoperative blood loss
- Need for dose adjustment intraoperatively
- Hemodynamic instability defined by hypotension (-20% from basal values prior to entering the OR, at the time of the consent).
- Post-operative
- Time to motor and sensory function return
- Time to mobilization
- Pain evaluated with Visual analog scale immediately after surgery and up to 72 hours after surgery
- Opioid consumption up to 48 hours
- Hospital LOS and incidence of failed discharge at planned time
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group
| Arm | Type | Receives |
|---|---|---|
| SA | Active comparator | Procedure: Spinal anesthesiaSA 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 | Procedure: Sedation epidural anesthesiaEA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaSpinal 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 or surgery | SA |
| Sedation epidural anesthesiaSedation-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 or surgery | SED-EA |
Primary outcome
Adverse Events
Time frame: Day 3
The number of overall adverse events will be categorized according to the Clavien-Dindo classification
17 secondary outcomes
Time needed by the anesthesiologist to perform the technique
Time frame: Day 0
Time needed for the SA or SED-EA to achieve adequate sensory block
Time frame: Day 0
Intraoperative blood loss
Time frame: Day 0
intraoperative muscle tension
Time frame: Day 0
Extra Lidocaine needed
Time frame: Day 0
Conversion to GA
Time frame: Day 0
Total dose of the sedation
Time frame: Day 0
Hemodynamic stability measured
Time frame: Day 0
Time to return of motor and sensory function
Time frame: Day 1
Post-operative nausea
Time frame: Day 1
PONV and anti-emetics
Time frame: Day 1
Urinary retention
Time frame: Day 1
Opioid consumption
Time frame: Day 2
Length of stay
Time frame: Day 2
Failed discharded
Time frame: Day 2
Complications related to the technique performed.
Time frame: Day 3
Adverse event
Time frame: Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Knee Injuries and Disorders
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina Morcos, Dr principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia and Sedation epidural anesthesia in people with Knee Injuries and Disorders and Hip Injuries, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge Marquis, inf (514-252-3400 ext. 5701, smarquis.hmr@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.