Clinical trial NCT05601427: Intra-Operative Adductor Canal Blocks
Official title: A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Pain Chronic
Anesthesia
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
First posted: 2022-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Primary TKA booked as SDD
3. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Inability or refusal to sign informed consent form
2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
3. Non-osteoarthritis primary diagnosis
4. Allergy to analgesic medications
5. Contraindication to spinal and/or regional anaesthesia
6. Any use of opioid pain medication within four weeks of the index procedure(13)
7. Pain catastrophizing scale score ≥16 (8, 9, 14)
8. History of cirrhosis
9. History renal insufficiency
10. History or sensory and/or motor neuropathy to the ipsilateral limb
11. Simultaneous, bilateral TKA
12. Non-TKA prosthesis
13. Scheduled for non-SDD TKA.
14. Preoperative varus/valgus of \>10 degrees.
15. Planned General Anaesthetic
16. Use of Intrathecal Morphine

Primary outcomes:
measure: Patient Report Pain
timeFrame: Up to 24 hours
measure: Pain medication use
timeFrame: When spinal anesthesia resolves until 24 hours after surgery
Secondary outcomes:
measure: Time to discharge
timeFrame: From PACU to discharge
measure: Admission to Hospital
timeFrame: Up to 24 hours post-operative
measure: Readmission Rate
timeFrame: Up to 24 hours post-operative
measure: Timed Up and Go Test
timeFrame: At discharge
measure: Patient Reported Quality of Recovery
timeFrame: At 24 hours post-operative
measure: Patient Reported Function
timeFrame: pre-operatively, at 2 weeks post-operative
measure: Patient Reported Quality of Life
timeFrame: pre-operatively, at 2 weeks post-operative
measure: Patient Reported Global Health
timeFrame: pre-operatively, at 2 weeks post-operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Simon Garceau, MD
role: PRINCIPAL_INVESTIGATOR
References: