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

226 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Adductor Canal Block, Adductor Canal Catheter Infusion, Periarticular Joint Injection, Ropivacaine, Naropin for knee replacement surgery?

Research shows that regional anesthesia, like the adductor canal block, is preferred for knee surgery as it helps with early pain relief, reduces the need for opioids, and improves mobility. Periarticular injections, including those with ropivacaine, are also used to improve pain relief after knee surgery. ^{1 2 3 4 5}

Is regional anesthesia for knee replacement surgery safe?

Research shows that using ropivacaine in knee replacement surgery is generally safe, with studies focusing on its cardiovascular safety and pain management benefits. Periarticular injections, including those with ropivacaine, are commonly used and considered safe for managing pain after knee surgery. ^{4 5 6 7 8}

How is the drug Ropivacaine used in knee replacement surgery different from other treatments?

Ropivacaine is used in a periarticular injection (injection around the joint) for knee replacement surgery, which can offer similar pain relief benefits to nerve blocks without causing muscle weakness or delays in physical therapy. This makes it a potentially more efficient option for managing postoperative pain and facilitating quicker recovery. ^{4 5 7 9 10}

What is the purpose of this trial?

To assess feasibility of a a trial investigation postoperative patient-reported quality of recovery after total knee arthroplasty (TKA) with periarticular joint injection (PAI) ± single shot adductor canal block with or without adductor canal catheter infusion.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Periarticular injection in knee arthroplasty improves quadriceps function. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial on Additional Efficacy of Periarticular Anesthesia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine vs Plain Bupivacaine in Periarticular Injection for Control of Pain and Early Motion in Total Knee Arthroplasty: A Randomized, Prospective Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Periarticular Ropivacaine Cocktail Is Equivalent to Liposomal Bupivacaine Cocktail in Bilateral Total Knee Arthroplasty. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Low-dose spinal bupivacaine for total knee arthroplasty facilitates recovery room discharge: a randomized controlled trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Does adding corticosteroids to periarticular injection affect the postoperative acute phase response after total knee arthroplasty? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Incidence of cardiovascular complications in knee arthroplasty patients before and after implementation of a ropivacaine local infiltration analgesia protocol: A retrospective study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Do Regional Analgesia and Peripheral Blocks Still Have a Place in Joint Arthroplasty? [2015]