Intra-Operative Adductor Canal Blocks

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05601427
• Collaborator: Canadian Orthopaedic Foundation (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 17

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic; Anesthesia	Procedure: aACB; Procedure: sACB	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anesthesiologist-Performed Adductor Canal Block (aACB) Patients will get a pre-operative adductor canal block performed by an anesthesiologist.	Procedure: aACB; 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.
Experimental: Surgeon-Performed Adductor Canal Block (sACB) Patients will get an intra-operative adductor canal block performed by the surgeon	Procedure: sACB; The patient will undergo an intraoperative single-shot ACB performed by the treating surgeon following placement of the TKA components.

Outcome Measures

Primary Outcome Measures

1. Patient Report Pain [Up to 24 hours]

   Mean Numerical Pain Rating Scale (NPRS) scores on discharge

2. Pain medication use [When spinal anesthesia resolves until 24 hours after surgery]

   morphine equivalents of pain medication

Secondary Outcome Measures

1. Time to discharge [From PACU to discharge]

   Post-operative time in minutes to discharge home

2. Admission to Hospital [Up to 24 hours post-operative]

   Failure to discharge home requiring admission

3. Readmission Rate [Up to 24 hours post-operative]

   Number of patients readmitted to the hospital within 24 hours

4. Timed Up and Go Test [At discharge]

   Time is takes, in seconds, to stand, walk 3m, turn around, walk back 3m, and sit back down

5. Patient Reported Quality of Recovery [At 24 hours post-operative]

   Score on the Quality of Recovery-15 questionnaire

6. Patient Reported Function [pre-operatively, at 2 weeks post-operative]

   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

7. Patient Reported Quality of Life [pre-operatively, at 2 weeks post-operative]

   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

8. Patient Reported Global Health [pre-operatively, at 2 weeks post-operative]

   Difference in scores on the PROMIS-10 - Global Health (questionnaire), which generates T-scores. Higher T-scores indicate better health.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ottawa Hospital Research Institute
• Canadian Orthopaedic Foundation

Investigators

• Principal Investigator: Simon Garceau, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT05601427
• Other Study ID Numbers: 20220573-01H
• First Posted: Nov 1, 2022
• Last Update Posted: Nov 1, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 1, 2022