NCT05601427

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

September 20, 2022

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Time to discharge

    From PACU to discharge

  • Admission to Hospital

    Up to 24 hours post-operative

  • Readmission Rate

    Up to 24 hours post-operative

  • Timed Up and Go Test

    At discharge

  • Patient Reported Quality of Recovery

    At 24 hours post-operative

  • +3 more secondary outcomes

Study Arms (2)

Anesthesiologist-Performed Adductor Canal Block (aACB)

ACTIVE COMPARATOR

Patients will get a pre-operative adductor canal block performed by an anesthesiologist.

Procedure: aACB

Surgeon-Performed Adductor Canal Block (sACB)

EXPERIMENTAL

Patients will get an intra-operative adductor canal block performed by the surgeon

Procedure: sACB

Interventions

aACBPROCEDURE

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.

Anesthesiologist-Performed Adductor Canal Block (aACB)
sACBPROCEDURE

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

Surgeon-Performed Adductor Canal Block (sACB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 years or older
  • Primary TKA booked as SDD
  • Diagnosis of osteoarthritis

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Simon Garceau, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjula Costa

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2022

First Posted

November 1, 2022

Study Start

March 22, 2023

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations