Nerve Block for Knee Surgery Pain

Overseen By Anthony Christiano, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Chicago

Must not be taking: Opioids, NSAIDs, Acetaminophen, Anesthetics

Disqualifiers: Anxiety, Chronic pain, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-surgery

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improved methods for managing pain after knee surgery. Researchers are testing whether injecting numbing medication directly into specific knee nerves (nerve block) offers better pain relief than the standard method of numbing around the surgical incision. The medication used is bupivacaine (also known as Marcaine or Sensorcaine). The trial seeks adults undergoing surgery for an isolated tibial plateau fracture who do not have chronic pain or substance use issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have chronic pain syndromes or use opioids, you may not be eligible to participate.

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

Research shows that genicular nerve blocks with bupivacaine are generally safe and can alleviate knee pain. One study found that individuals receiving a genicular nerve block required fewer opioids (strong painkillers) after knee surgery. Another study demonstrated that these nerve blocks provided better pain relief than a saltwater injection.

Although specific safety data for using bupivacaine in genicular nerve blocks during this trial phase is limited, bupivacaine is already used in other medical procedures, and doctors are familiar with its safety profile. It is usually well-tolerated, but like any drug, it can cause side effects, such as numbness, dizziness, or a metallic taste. Serious side effects are rare but possible.

Overall, current research suggests that genicular nerve blocks with bupivacaine are safe. This trial aims to further assess its safety and effectiveness in managing knee surgery pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about this trial because it explores two different approaches to managing post-surgery knee pain using bupivacaine. The first approach, peri-incisional local anesthesia, involves injecting bupivacaine directly at the incision sites, which is the standard method for numbing pain. However, the experimental genicular nerve blockade technique is particularly intriguing as it targets specific nerves around the knee with precision using fluoroscopic guidance. This method could potentially offer more effective pain relief by blocking nerve signals before they reach the central nervous system, providing a novel way to manage pain with potentially fewer side effects than traditional methods.

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

This trial will compare two methods for managing pain after knee surgery. Participants in one arm will receive a genicular nerve block with bupivacaine. Research has shown that this can reduce pain and decrease the need for opioids in the first 24 hours after surgery. Using fewer opioids is important because it can lead to fewer side effects and a faster recovery. Other studies suggest that genicular nerve blocks are safe and effective for reducing long-term knee pain. Meanwhile, participants in another arm will receive peri-incisional local anesthesia, involving an injection of bupivacaine at the time of wound closure. These findings are promising for managing pain after knee surgery with these techniques. ^{1 4 6 7 8}

Who Is on the Research Team?

Anthony Christiano, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals who have had knee surgery due to a broken bone in the tibial plateau. Participants should be interested in better pain management post-surgery.

Inclusion Criteria

I am an adult having surgery for a recent isolated tibial plateau fracture.

Exclusion Criteria

I am under 18 years old.

I have a history of or currently experience anxiety.

I cannot use ketorolac due to kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either peri-incisional local anesthesia or genicular nerve block at the time of wound closure

Immediate post-surgery

1 visit (in-person, during surgery)

Postoperative Monitoring

Participants' pain levels and range of motion are assessed at one hour, two hours, and at PACU discharge

PACU stay

Continuous monitoring during PACU stay

Follow-up

Participants are monitored for pain control and opiate use for the first three days after surgery and at 2 weeks post-surgery

2 weeks

Daily assessments for first 3 days, follow-up at 2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The study is testing if injecting Bupivacaine, a numbing medication, directly into the genicular nerve provides better pain control after knee surgery than standard treatment.

How Is the Trial Designed?

Group I: Genicular nerve blockade Experimental Treatment 1 Intervention

Subjects randomized to genicular nerve block will receive a fluoroscopic guided injection of 5 ml of 0.25% bupivacaine at the described locations of the superolateral genicular nerve, super medial genicular nerve, inferomedial genicular nerve, recurrent fibular nerve, and infrapatellar branch of the saphenous nerve under fluoroscopic guidance at the time of wound closure

Group II: Peri-incisional local anesthesia Active Control 1 Intervention

subjects randomized to peri-incisional local anesthesia administration will receive an injection of 25 ml of 0.25% bupivacaine across all incisions at the time of wound closure (standard of care)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Peripheral nerve blocks used alongside systemic analgesia significantly reduce pain intensity after major knee surgery, with lower pain scores reported at all time intervals within 72 hours post-surgery, based on a review of 23 studies involving 1571 participants.

While peripheral nerve blocks show promise for pain management, there is insufficient data to compare their effectiveness against local infiltration, epidural, or spinal analgesia, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Peripheral nerve blocks for postoperative pain after major knee surgery. Xu, J., Chen, XM., Ma, C., et al.[2023]

In a randomized double-blind controlled trial involving 79 patients, intraarticular bupivacaine was found to be an effective method for pain relief after arthroscopic meniscectomy.

The study demonstrated that bupivacaine is a safe option for managing postoperative pain, providing a beneficial alternative to saline placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular bupivacaine (Marcaine) after arthroscopic meniscectomy: a randomized double-blind controlled study. Chirwa, SS., MacLeod, BA., Day, B.[2019]

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

In a study involving 20 patients recovering from knee-joint surgery, a continuous lumbar plexus block with bupivacaine significantly reduced pain scores and decreased the need for morphine compared to a placebo (sodium chloride).

No side effects related to the catheter or bupivacaine infusion were observed, indicating that this method is both effective and safe for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous blockade of the lumbar plexus after knee surgery--postoperative analgesia and bupivacaine plasma concentrations. A controlled clinical trial. Dahl, JB., Christiansen, CL., Daugaard, JJ., et al.[2019]

The addition of intravenous dexmedetomidine (DexM) to systemic dexamethasone did not significantly prolong the duration of analgesia provided by quadruple nerve blocks in patients undergoing total knee arthroplasty, with similar median durations of analgesia in both DexM and placebo groups.

While DexM did not enhance pain relief, it was associated with side effects such as bradycardia and hypotension, leading to a longer recovery room stay, indicating potential safety concerns when used in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration. Chassery, C., Marty, P., Rontes, O., et al.[2021]

A femoral nerve block using bupivacaine provided effective postoperative pain relief for 46 out of 50 patients after knee surgery, demonstrating a high success rate of 92%.

The average duration of analgesia was 600 minutes, with some patients experiencing relief for up to 1,200 minutes, indicating that this technique is both safe and reliable for managing pain after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Femoral nerve block as a postoperative analgesia technic in surgery of the knee]. Davidas, JL., Rondelet, B., Besson, L., et al.[2019]

Peripheral nerve blocks used alongside systemic analgesia significantly reduce pain intensity after major knee surgery, with lower pain scores reported at all time intervals within 72 hours post-surgery, based on a review of 23 studies involving 1571 participants.

While peripheral nerve blocks show promise for pain management, there is insufficient data to compare their effectiveness against local infiltration, epidural, or spinal analgesia, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve blocks for postoperative pain after major knee surgery. Xu, J., Chen, XM., Ma, CK., et al.[2022]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

In a study of 75 patients undergoing total knee replacement, combining spinal anaesthesia with femoral and sciatic nerve blocks significantly prolonged the time to first morphine request (912 minutes for bupivacaine and 781 minutes for ropivacaine) compared to spinal anaesthesia alone (413 minutes).

Both bupivacaine and ropivacaine used in the nerve blocks effectively reduced morphine consumption without causing any systemic or neurological side effects, indicating their safety and efficacy in post-operative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee replacement: a comparison of ropivacaine and bupivacaine in combined femoral and sciatic block. McNamee, DA., Convery, PN., Milligan, KR.[2019]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161999/

Genicular nerve block with corticosteroid for chronic knee ... For the majority of patients who received GNB with corticosteroid, we observed statistically and clinically significant pain reduction for 3 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424000086

Effectiveness comparison of genicular nerve ablation for ... In reality, outcomes are often poorer after revision TKR compared with primary TKR; nearly half of patients report severe chronic post-operative pain [7].

3. rapm.bmj.com rapm.bmj.com/content/46/10/862.abstract

Ultrasound-guided genicular nerve blocks following total ... Genicular nerve blockade was associated with a reduction in opioid consumption at 24 hours in primary total knee arthroplasty patients.

4. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2025.1601708/full

Bedside ultrasound-guided genicular nerve block with ... Conclusions: The US GNB is safe to perform for inpatients undergoing rehabilitation who experience pain from knee OA. We found that in nearly ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/anrp/8827996

The Role of Genicular Nerve Blocks in Enhancing ... Genicular nerve blocks (GNBs) have been used to help relieve chronic knee pain [14–16] and have recently attracted attention as a possible ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1063458425008234

Efficacy and safety of minimally invasive interventions ... This meta-analysis of 25 trials (n=2049 participants) found that minimally invasive interventions may result in moderate short-term pain reduction compared to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03316118

US Guided GNB vs Saline Injection for TKA Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery ...

8. cureus.com cureus.com/articles/321881-genicular-nerve-block-versus-genicular-nerve-ablation-for-knee-osteoarthritis-a-systematic-review-of-randomized-controlled-trials-and-retrospective-studies

Genicular Nerve Block Versus Genicular Nerve Ablation for ... Of the subjects that proceeded to genicular nerve ablation, 53.7% reported less than 50% pain relief, and 46.3% reported pain relief greater ...