Intra-Operative Adductor Canal Blocks

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601427
• Other study ID #: 20220573-01H
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Meaghan Dufresne
• Phone: 613-737-8899
• Email: meadufresne[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• sACB
The patient will undergo an intraoperative single-shot ACB performed by the treating surgeon following placement of the TKA components.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Orthopaedic Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Report Pain	Mean Numerical Pain Rating Scale (NPRS) scores on discharge	Up to 24 hours
Primary	Pain medication use	morphine equivalents of pain medication	When spinal anesthesia resolves until 24 hours after surgery
Secondary	Time to discharge	Post-operative time in minutes to discharge home	From PACU to discharge
Secondary	Admission to Hospital	Failure to discharge home requiring admission	Up to 24 hours post-operative
Secondary	Readmission Rate	Number of patients readmitted to the hospital within 24 hours	Up to 24 hours post-operative
Secondary	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
Secondary	Patient Reported Quality of Recovery	Score on the Quality of Recovery-15 questionnaire	At 24 hours post-operative
Secondary	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
Secondary	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
Secondary	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