Regional Anesthesia for Knee Replacement Surgery

(TRUE KnORTH 2 Trial)

Overseen By Kim Wong, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

Must not be taking: Opioids, Acetaminophen

Disqualifiers: Obesity, Renal insufficiency, Chronic opioid use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different anesthesia methods affect recovery after knee replacement surgery. Researchers are comparing two types of pain relief: one involves a medication injection around the knee joint (periarticular joint injection), a local anesthetic block (adductor canal block), and continuous pain relief infusion (adductor canal catheter infusion). The other uses the same approach but with a placebo (inactive treatment) infusion. The goal is to identify which method improves patient recovery after surgery. The trial seeks adults planning their first knee replacement surgery who can receive regional anesthesia (pain relief targeting a specific area of the body). As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you have an allergy or intolerance to the study medications, you may not be eligible to participate.

What is the safety track record for these treatments?

Previous studies have shown that injections around the knee joint with ropivacaine reduce pain after knee surgery without increasing side effects. Patients generally tolerated it well. Research also shows that adductor canal blocks, a type of nerve block, are safe and effective for pain relief after knee replacement. Both treatments appear to be well-tolerated and carry a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using regional anesthesia techniques, like periarticular joint injections combined with ropivacaine, for knee replacement surgery because they offer potentially enhanced pain control with fewer side effects compared to traditional systemic pain medications, such as opioids. Unlike standard treatments that often rely on oral painkillers, this approach directly targets the surgical area, potentially providing more effective pain relief while minimizing the risk of systemic side effects. Additionally, using a catheter for continuous infusion can offer prolonged pain management post-surgery, which is especially beneficial for patient recovery and mobility.

What evidence suggests that this trial's treatments could be effective for knee replacement surgery?

Research has shown that injecting ropivacaine around the knee joint effectively reduces pain shortly after knee surgery. These injections facilitate easier knee movement and decrease the need for pain medication. In this trial, participants may receive a single-shot adductor canal block, which numbs a specific leg nerve to enhance pain relief. Alternatively, some participants will receive a continuous infusion through an adductor canal catheter, providing even better pain control in the days following surgery. Both methods are safe and help patients manage pain effectively after knee replacement. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who are about to have their first knee replacement surgery. It's testing different pain management techniques after the operation. People can't join if they don't meet certain health requirements or conditions that the study outlines.

Inclusion Criteria

I am an adult scheduled for my first total knee replacement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with periarticular joint injection and adductor canal block

Up to 3 days

In-hospital stay

Postoperative Monitoring

Patient-reported outcomes and pain management are assessed, including Quality of Recovery and pain interference scores

42 days

Postoperative days 0, 1, 2, 3, 10, and 42

Follow-up

Participants are monitored for safety and effectiveness after treatment, including narcotic consumption and functional recovery

42 days

What Are the Treatments Tested in This Trial?

Interventions

• Adductor Canal Block
• Adductor Canal Catheter Infusion
• Periarticular Joint Injection
• Ropivacaine

Trial Overview The study is looking at how well patients recover from knee surgery using two pain relief methods: injections with a drug called Ropivacaine, and normal saline, which is like saltwater. Some will also get an extra numbing technique in the thigh area.

How Is the Trial Designed?

Group I: cACB active Experimental Treatment 1 Intervention

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)

Group II: cACB sham Placebo Group 1 Intervention

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a study involving 32 patients undergoing knee arthroplasty, both liposomal bupivacaine (EXP) and a combination of ropivacaine, epinephrine, ketorolac, and clonidine (ROP) provided similar pain relief, with no significant differences in pain scores during the first two days post-surgery.

Patients did not perceive any difference in functional recovery between the two injection types, indicating that the more expensive liposomal bupivacaine does not offer additional benefits over the standard ROP formulation for pain management after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periarticular Ropivacaine Cocktail Is Equivalent to Liposomal Bupivacaine Cocktail in Bilateral Total Knee Arthroplasty. Danoff, JR., Goel, R., Henderson, RA., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5129513/

Analgesic Efficacy of Adductor Canal Block in Total Knee ... Our results suggest that, compared with saline, ACB decreases analgesic consumption and offers short‐term advantages in terms of pain relief.

2. sciencedirect.com sciencedirect.com/science/article/pii/S277260962500005X

Review Article Adductor canal block in total knee arthroplasty Adductor canal block is a safe and potentially effective peripheral nerve block for reducing postoperative pain after total knee arthroplasty while preserving ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40177059/

Adductor canal block in total knee arthroplasty: a scoping ... Adductor canal block is a safe and potentially effective peripheral nerve block for reducing postoperative pain after total knee arthroplasty while preserving ...

4. kneesurgrelatres.biomedcentral.com kneesurgrelatres.biomedcentral.com/articles/10.1186/s43019-023-00188-0

The effects of continuous catheter adductor canal block for ... Our meta-analysis appears to demonstrate that continuous administration of analgesia through an adductor canal catheter provides greater pain reduction in ...

5. rapm.bmj.com rapm.bmj.com/content/early/2025/09/10/rapm-2025-106991

Outpatient continuous adductor canal block (CACB) for ... Single-injection adductor canal blocks (SACB) provide effective but short-lived pain relief after total knee arthroplasty, with limited ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964494/

Adductor canal block in total knee arthroplasty Adductor canal block is a safe and potentially effective peripheral nerve block for reducing postoperative pain after total knee arthroplasty while preserving ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05100706

Continuous Adductor Canal Block in Outpatient Total Knee ... We hypothesize that continuous adductor canal block would lead to a better quality of recovery in patients undergoing primary TKA. Detailed Description.

8. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00306-1/abstract

Intraoperative Surgeon-Administered Adductor Canal ... A randomized non-Inferiority trial of adductor canal block for analgesia after total knee arthroplasty: single injection versus catheter technique