Nerve Block for Knee Surgery Pain Control

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Opioids

Disqualifiers: Revision surgery, Bilateral surgery, Workers compensation, Inflammatory arthritis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

130 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to investigate whether the addition of a surgeon-administered adductor canal blockade to a multimodal periarticular injection cocktail provides additional pain relief for patients undergoing total knee arthroplasty. This study will help identify the effectiveness of surgeon-administered adductor canal blockade in perioperative pain control for patients undergoing total knee arthroplasty

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking opioids, you would not be eligible to participate.

What data supports the effectiveness of the drug Ropivacaine injection for knee surgery pain control?

Research shows that Ropivacaine is effective for pain relief in knee surgeries, as it provides good pain control when used in nerve blocks, similar to other local anesthetics like bupivacaine. It has been shown to have a faster recovery of sensation and movement compared to bupivacaine, which can be beneficial for postoperative recovery. ^{1 2 3 4 5}

Is ropivacaine safe for use in humans?

Ropivacaine is generally considered safe for use in humans, with studies showing it to be less toxic to the central nervous system and heart compared to bupivacaine, another local anesthetic. No adverse effects were observed in studies involving nerve blocks, making it a preferred choice for long-lasting anesthesia. ^{1 6 7 8 9}

How does the nerve block treatment for knee surgery pain control differ from other treatments?

The nerve block treatment for knee surgery pain control is unique because it uses a targeted approach to block specific nerves around the knee, such as the femoral-sciatic or saphenous nerves, often guided by ultrasound. This method can provide effective pain relief while preserving muscle strength, which is different from other treatments like periarticular injections that may not be as precise in targeting pain pathways. ^{1 2 3 10 11}

Research Team

Bryan Springer, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Eligibility Criteria

This trial is for individuals aged 30-85 who are having their first total knee replacement due to osteoarthritis and will stay in the hospital overnight. It's not for those who have taken opioids before surgery, need a revision or bilateral knee replacement, have post-traumatic or inflammatory arthritis, previous surgeries on that knee, same-day discharge plans, contralateral knee replacements, or a history of substance abuse.

Inclusion Criteria

I am between 30-85 years old and having my first knee replacement due to arthritis, staying in the hospital overnight.

Exclusion Criteria

I have inflammatory arthritis.

I am having knee replacement surgery and will go home the same day.

I have had surgery that opened my knee joint before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo total knee arthroplasty with either a periarticular injection and adductor canal block or a periarticular injection with saline

1 day

1 visit (in-person)

Postoperative Monitoring

Patients are monitored for pain and recovery, including pain scores and physical therapy assessments

7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including range of motion and patient satisfaction

4-6 weeks

1 visit (in-person)

Treatment Details

Interventions

• Ropivacaine injection

Trial Overview The study is testing if adding an adductor canal block with ropivacaine (a numbing medication) to standard pain relief methods provides better pain control after knee replacement surgery than using saline (a placebo). Patients receive either the real drug or saline alongside regular pain management.

Participant Groups

Group I: Treatment Group (Ropivacaine) Experimental Treatment 2 Interventions

The treatment group will consist of patients undergoing total knee arthroplasty who receive standardized 100 cc periarticularinjection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients will then receive 10cc of ropivacaineinto their adductor canal.This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.

Group II: Control Group (Saline) Placebo Group 2 Interventions

The control group will consist of patients undergoing total knee arthroplasty who receive a standardized periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients randomized in this group will then receive 10cc of saline into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Towson Orthopaedic Associates

Collaborator

Trials

2

Recruited

290+

Findings from Research

In a study of 105 patients undergoing knee arthroscopy, a 0.20% concentration of ropivacaine was found to provide effective postoperative pain relief while allowing for better mobility compared to higher concentrations.

Higher concentrations of ropivacaine (0.50%) resulted in significantly greater motor blockade, indicating that lower concentrations may be preferable for balancing pain management and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal effective concentration of ropivacaine for postoperative analgesia by single-shot femoral-sciatic nerve block in outpatient knee arthroscopy. Yao, J., Zeng, Z., Jiao, ZH., et al.[2018]

Ropivacaine, compared to bupivacaine, shows a greater margin of safety in terms of systemic toxicity across different age groups, with higher doses required to induce toxicity in infants than in adults.

The duration of nerve blockade from ropivacaine is longer in infant rats than in older rats, indicating its potential effectiveness in pediatric applications, although its overall efficacy is similar to that of bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sciatic nerve blockade in infant, adolescent, and adult rats: a comparison of ropivacaine with bupivacaine. Kohane, DS., Sankar, WN., Shubina, M., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Optimal effective concentration of ropivacaine for postoperative analgesia by single-shot femoral-sciatic nerve block in outpatient knee arthroscopy. [2018]

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

The efficacy of levobupivacaine, ropivacaine, and bupivacaine for combined psoas compartment-sciatic nerve block in patients undergoing total hip arthroplasty. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of ultrasound-guided selective sensory nerve blockade of the knee on pain management compared with periarticular injection for patients undergoing total knee arthroplasty: A prospective randomized controlled trial. [2022]

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

Clinical properties of levobupivacaine or racemic bupivacaine for sciatic nerve block. [2019]

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

The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. [2018]

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

Sciatic nerve blockade in infant, adolescent, and adult rats: a comparison of ropivacaine with bupivacaine. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Levobupivacaine versus ropivacaine in psoas compartment block and sciatic nerve block in orthopedic surgery of the lower extremity. [2018]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Clinical application of ropivacaine for the upper extremity. [2019]

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

Local anesthetic efficacy of ropivacaine (LEA 103) in ulnar nerve block. [2018]

10. Italy pubmed.ncbi.nlm.nih.gov

Minimum local anesthetic volumes for a selective saphenous nerve block: a dose-finding study. [2019]

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

Single-Injection Adductor Canal Block With Multiple Adjuvants Provides Equivalent Analgesia When Compared With Continuous Adductor Canal Blockade for Primary Total Knee Arthroplasty: A Double-Blinded, Randomized, Controlled, Equivalency Trial. [2019]