Nerve Block for Knee Surgery Pain Control

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage pain for individuals undergoing total knee replacement surgery. Researchers aim to determine if adding a special nerve block with ropivacaine, a local anesthetic injection, provides better pain relief than the standard treatment. Participants will receive either ropivacaine or a placebo (a harmless saline solution) during surgery. This trial targets individuals having their first knee replacement due to osteoarthritis and who plan to stay in the hospital for at least one night. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking pain management solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that using high-dose ropivacaine for numbing during knee surgery was safe, as it did not cause serious side effects. Another study demonstrated that ropivacaine for regional anesthesia can enhance patient satisfaction with their surgery experience and reduce postoperative complications. Reports of local anesthetic systemic toxicity (LAST), a serious condition that can occur if too much anesthetic enters the bloodstream, are rare with ropivacaine. In one study, no definite cases of this toxicity were identified. Ropivacaine is generally well-tolerated at recommended doses of 3-4 mg per kg of body weight, with a maximum of 250 mg when combined with epinephrine. Overall, research has shown that ropivacaine is safe for surgeries like knee replacements. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard of care for knee surgery pain relief, which often involves oral medications like opioids and NSAIDs, ropivacaine is administered directly into the adductor canal near the knee. This targeted delivery method is exciting because it could provide effective pain relief directly at the site, potentially reducing the need for systemic painkillers that come with more side effects. Researchers are particularly interested in ropivacaine's ability to offer precise, localized pain control, which could result in a faster recovery and fewer complications compared to traditional pain management options.

What evidence suggests that this treatment might be an effective treatment for knee surgery pain control?

Research has shown that ropivacaine can help control pain during total knee replacement surgery. In this trial, participants in the treatment group will receive ropivacaine as part of their pain management plan. One study found that mixing ropivacaine with other medications reduced pain and provided longer-lasting relief after surgery. Another study demonstrated that using ropivacaine in a nerve block during knee surgery improved pain management. Although some studies did not find a significant difference when using ropivacaine alone, it is often combined with other treatments for enhanced effectiveness. These findings suggest that ropivacaine can be part of an effective pain relief plan during knee surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Bryan Springer, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2926371/

A Randomized Controlled Trial of Intraarticular Ropivacaine ... Intraarticular ropivacaine used for pain control after TKA demonstrated no statistically significant difference in lowering VAS scores or narcotic usage.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7229799/

Comparison of Effectiveness of Ropivacaine Infusion ... Continuous femoral nerve block (cFNB) is effective for analgesia after total knee arthroplasty (TKA). However, it is not clear which low-dose ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540309000953

Posterior Capsular Injections of Ropivacaine During Total ... We investigated the hypothesis that a posterior capsular injection of ropivacaine would improve pain and accelerate functional recovery after total knee ...

4. link.springer.com link.springer.com/article/10.1007/s00402-024-05719-2

Local infiltration anesthesia with high dose ropivacaine ... LIA in a combination of single high-dose ropivacaine and dexmedetomidine is safe in knee surgery. Further studies evaluating pain relief with this LIA ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/3697846

Cocktail of Ropivacaine, Morphine, and Diprospan ... Cocktail of Ropivacaine, Morphine, and Diprospan reduces pain and prolongs analgesic effects after total knee arthroplasty: a prospective randomized controlled ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10508276/

Systemic Ropivacaine Concentrations Following Local ... Regional anesthetic techniques have been shown to significantly improve patient satisfaction and reduce postoperative complications after total ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11698751/

Local infiltration anesthesia with high dose ropivacaine and ... LIA in a combination of single high-dose ropivacaine and dexmedetomidine is safe in knee surgery. Further studies evaluating pain relief with this LIA ...

8. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(25)00524-0/fulltext

Systemic toxicity and transient locked-in-like syndrome ... Cases of local anaesthetic systemic toxicity (LAST) associated with this technique have rarely been reported. We encountered a LAST event after ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818024001636

A single center descriptive study of local anesthetic dose in ... No definitive local anesthetic toxicity events were observed in this retrospective single-center study. •. Maximum recommended doses of bupivacaine and ...

10. psnet.ahrq.gov psnet.ahrq.gov/web-mm/local-anesthesia-induced-coma-during-total-knee-arthroplasty

Local Anesthesia-Induced Coma During Total Knee ... The maximum 'safe' doses for ropivacaine are 3 mg/kg (maximum dose 200mg) or 3-4 mg/kg (maximum dose 250mg) if combined with epinephrine. In the ...