Clinical trial NCT04648072: How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.
Official title: Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthritis Knee
Knee Disease
Opioid Use
Keywords: Quality of Recovery-15 Survey
Peripheral Nerve Block
Local Infiltration
Adductor Canal Block
Periarticular Injection
Regional Anesthesia
Total Knee Arthroplasty
Orthopedics
Total Knee Replacement
Lead sponsor: Health Sciences North Research Institute
Sponsor class: OTHER
Collaborators: name: Dedicated Anesthesia Research Enhancement Grant
First posted: 2020-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial. Two arms of 30 participants will be included in this study. The experimental arm will receive both the periarticular injection and the adductor canal block with local anesthetic, while the control group will receive the periarticular injection and a sham adductor canal block with normal saline.
Primary purpose: TREATMENT

Brief summary: The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.

Detailed description: This study is a double blinded, randomized control trial. In order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (ACB) and a periarticular injection (PI). All syringes will be non-identifiable to the surgeon, anesthetist and the patient.

Specifically, the two arms are:

Arm 1: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Ropivacaine)

Arm 2: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Normal Saline)

The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. The investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.

Eligibility criteria: Inclusion Criteria:

1. Patients requiring primary total knee arthroplasty
2. Patients interested in being part of the study
3. Eligible to receive spinal anesthesia

Exclusion Criteria:

1. Age \< 18 years
2. BMI \> 40 kg/m2
3. Deemed unsuitable for regional anesthesia
4. Planned general anesthesia
5. Hepatic insufficiency/Intolerance to acetaminophen
6. Renal insufficiency (defined by eGFR \<60)
7. Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine, per hour for greater than 1 month)
8. Sulpha allergy
9. Allergy or intolerance to trial medications
10. Clinical Frailty Scale Score \> 4
11. Surgery scheduled on a weekend

Primary outcomes:
measure: Scoring on the Quality of Recovery-15 Survey
timeFrame: Up to 4 weeks post-operatively.
measure: Feasibility Outcomes
timeFrame: End of project
Secondary outcomes:
measure: Postoperative Pain
timeFrame: Throughout hospital stay, an average of 1-2 days.
measure: Range of Motion
timeFrame: Throughout hospital stay, an average of 1-2 days.
measure: Time to Meet Discharge Criteria
timeFrame: Throughout hospital stay, an average of 1-2 days.
measure: Narcotic Consumption
timeFrame: Up to 4 weeks post-operatively.
measure: Timed Up and Go (TUG) Test
timeFrame: Throughout hospital stay, an average of 1-2 days.
Other outcomes:
measure: Opioid-Related Side Effects (Vomiting & Pruritus)
timeFrame: Throughout hospital stay, an average of 1-2 days.
Locations:
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
Study officials:
affiliation: Health Sciences North
name: Kim Wong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: