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

Trial Summary

What is the purpose of this trial?

The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.

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.

What data supports the effectiveness of the drug Bupivacaine (Marcaine) for reducing pain after knee surgery?

Research shows that Bupivacaine, used in nerve blocks, is effective in reducing pain after surgeries, including knee surgeries. It is also used successfully in other procedures, like childbirth, with minimal side effects, suggesting its effectiveness and safety in managing pain. ^{1 2 3 4 5}

Is bupivacaine (Marcaine, Sensorcaine) safe for use in humans?

Bupivacaine, also known as Marcaine or Sensorcaine, is generally considered safe for use in humans when used at recommended doses. It has been used effectively and safely for pain relief in various medical procedures, including knee surgery, with minimal side effects reported. ^{1 2 6 7 8}

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

The nerve block treatment for knee surgery pain is unique because it involves a localized and site-specific technique that uses bupivacaine to block pain signals in the nerves around the knee, providing effective pain relief without the need for systemic painkillers like morphine. This method can offer longer-lasting pain relief compared to other treatments like systemic, local infiltration, epidural, and spinal analgesia. ^{4 9 10 11 12}

Research Team

Anthony Christiano, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Total knee replacement: a comparison of ropivacaine and bupivacaine in combined femoral and sciatic block. [2019]

5. England 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. [2021]

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

Intraarticular bupivacaine (Marcaine) after arthroscopic meniscectomy: a randomized double-blind controlled study. [2019]

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

Postoperative pain relief using local anesthetic instillation. [2019]

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

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[Femoral nerve block as a postoperative analgesia technic in surgery of the knee]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Continuous blockade of the lumbar plexus after knee surgery--postoperative analgesia and bupivacaine plasma concentrations. A controlled clinical trial. [2019]

11. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Peripheral nerve blocks for postoperative pain after major knee surgery. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve blocks for postoperative pain after major knee surgery. [2022]