Intra-Operative Adductor Canal Blocks

Study Overview
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Brief Summary
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Adductor canal blocks (ACB) have been recommended in total knee arthroplasty (TKA) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. ACB is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. Recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sACB) during surgery. However, there is currently very limited data on the clinical efficacy of such sACBs, and no studies assessing this technique in the context TKA that are discharged the same day. As such, this randomized control trial (RCT) is being done to compare sACBs to conventional anesthesiologist-performed adductor canal blocks (aACB).

Official Title
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A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty

Conditions
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Knee Pain Chronic, Knee Osteoarthritis, Knee Arthritis, Anesthesia

Intervention / Treatment
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* Procedure: aACB
* Procedure: sACB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18 years or older Primary TKA booked as SDD Diagnosis of osteoarthritis Exclusion Criteria: Inability or refusal to sign informed consent form Non-English or French speaking, and no licensed translator, family member or substitute decision maker available. Non-osteoarthritis primary diagnosis Allergy to analgesic medications Contraindication to spinal and/or regional anaesthesia Any use of opioid pain medication within four weeks of the index procedure(13) Pain catastrophizing scale score ≥16 (8, 9, 14) History of cirrhosis History renal insufficiency History or sensory and/or motor neuropathy to the ipsilateral limb Simultaneous, bilateral TKA Non-TKA prosthesis Scheduled for non-SDD TKA. Preoperative varus/valgus of >10 degrees. Planned General Anaesthetic Use of Intrathecal Morphine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anesthesiologist-Performed Adductor Canal Block (aACB)<br>Patients will get a pre-operative adductor canal block performed by an anesthesiologist. | Procedure: aACB<br>* The patient will undergo a pre-operative single-shot, ultrasound-guided ACB performed by an anaesthesiologist skilled in regional anaesthesia techniques. The ACB will be performed in a dedicated block room, immediately prior to administration of a spinal anaesthetic.<br>|
| Experimental: Surgeon-Performed Adductor Canal Block (sACB)<br>Patients will get an intra-operative adductor canal block performed by the surgeon | Procedure: sACB<br>* The patient will undergo an intraoperative single-shot ACB performed by the treating surgeon following placement of the TKA components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Report Pain | Mean Numerical Pain Rating Scale (NPRS) scores on discharge | Up to 24 hours | 
| Pain medication use | morphine equivalents of pain medication | When spinal anesthesia resolves until 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | Post-operative time in minutes to discharge home | From PACU to discharge | 
| Admission to Hospital | Failure to discharge home requiring admission | Up to 24 hours post-operative | 
| Readmission Rate | Number of patients readmitted to the hospital within 24 hours | Up to 24 hours post-operative | 
| Timed Up and Go Test | Time is takes, in seconds, to stand, walk 3m, turn around, walk back 3m, and sit back down | At discharge | 
| Patient Reported Quality of Recovery | Score on the Quality of Recovery-15 questionnaire | At 24 hours post-operative | 
| Patient Reported Function | Difference in scores on the Oxford knee score (questionnaire), rated from 0-48 with 48 being the best functional outcome and 0 being the worst | pre-operatively, at 2 weeks post-operative | 
| Patient Reported Quality of Life | Difference in scores on the EQ-5D-5L questionnaire (Euro Quality of Life, 5 Dimension, 5 Level), rated from 11111 - 55555, with 11111 being full health and 55555 being worst health | pre-operatively, at 2 weeks post-operative | 
| Patient Reported Global Health | Difference in scores on the PROMIS-10 - Global Health (questionnaire), which generates T-scores. Higher T-scores indicate better health. | pre-operatively, at 2 weeks post-operative |