- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06784882
Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty
A Pilot Randomized Controlled Trial Assessing Pain and Opioid Outcomes Among Patients Undergoing Total Knee Arthroplasty Receiving 5-Day Outpatient Adductor Canal Continuous Versus Single Injection Blocks
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.
Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rodney A Gabriel, MD
- Phone Number: 858-663-7747
- Email: ragabriel@health.ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- University of California, San Diego
-
Contact:
- Rodney Gabriel
- Phone Number: 8586637747
- Email: ragabriel@health.ucsd.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult participants of at least 18 years of age
- Undergoing a primary, unilateral, total knee arthroplasty
- Planned single-injection adductor canal nerve block
- Weight > 50 kg (to minimize the risk of local anesthetic toxicity)
Exclusion Criteria:
- chronic opioid or tramadol use: daily oxycodone equivalents > 20 mg for > 4 weeks
- neuro-muscular deficit of the surgical limb
- moderate pain (NRS > 3) in an anatomic location other than the surgical site
- planned hospital admission following surgery
- history of opioid misuse
- those who lack capacity to complete informed consent
- inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
- incarceration
- pregnancy
- allergy to amide local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Continuous adductor canal block
single injection with ropivacaine (0.5%) of the adductor canal block and a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group)
|
For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.
|
|
Active Comparator: single injection adductor canal block
single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added
|
An adductor canal single injection nerve block will be performed per standard of care.
The adductor canal will be identified by ultrasound in the short-axis view.
The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb.
Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjacent to the femoral artery.
Twenty milliliters of ropivacaine 0.5% will be injected in divided doses with repeated negative aspiration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Time Frame: 7 days
|
Numeric Rating Scale (NRS) for pain will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured by the "average" daily NRS within the Brief Pain Inventory)
|
7 days
|
|
opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Time Frame: 7 days
|
Opioid consumption will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (measured in oxycodone equivalents)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
Time Frame: 7 days
|
The physical and emotional functioning of research participants will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured with the Brief Pain Inventory Interference Subscale)
|
7 days
|
|
improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
Time Frame: 30 days
|
Knee injury and osteoarthritis outcome score for joint replacement (KOOS JR)
|
30 days
|
|
30-day pain score measured in Numeric Rating Scale
Time Frame: 30 days
|
At around 30 days postoperatively, the patients average pain score measured in the numeric rating scale (0-10) will be assessed.
|
30 days
|
|
30-day postoperative opioid consumption
Time Frame: 30 days
|
Around 30 days postoperatively, the average opioid consumption will be assessed.
This will be based on the average opioid consumption over the preceding week at 30 days.
|
30 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 811228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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