Lidocaine + Ketamine vs Paravertebral Block for Rib Fractures

No longer recruiting at 1 trial location

Overseen By Susan Kartiko, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: George Washington University

Disqualifiers: Age, GCS, Intubation, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for managing pain in individuals with rib fractures. Researchers aim to determine if a combination of lidocaine and ketamine infusions, a type of pain management therapy, is as effective as the more common paravertebral block. The goal is to control pain sufficiently to improve breathing and reduce the risk of pneumonia or the need for a ventilator. This trial suits those hospitalized with rib fractures who have not found relief with standard pain medications and are experiencing difficulty breathing or coughing. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Previous studies have shown that both lidocaine and ketamine infusions are safe for managing pain in patients with rib fractures. Research has demonstrated that these infusions can effectively reduce the need for other pain medications, which often have more side effects. Importantly, patients have tolerated these medications well when used individually.

Paravertebral blocks involve injecting a numbing medication like ropivacaine near the spinal nerves. Studies have found this method to be safe and effective for controlling pain in patients with rib fractures, helping manage pain without significant side effects.

While both treatments have shown safety individually, using lidocaine and ketamine together is relatively new for this specific purpose. The current trial aims to compare this combination to the established method of the paravertebral block. Safety data from these studies provide reassurance, but more research is needed to fully understand the safety of using lidocaine and ketamine together for rib fracture pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to manage pain from rib fractures. Unlike traditional methods that often rely on systemic pain relief, the lidocaine and ketamine infusion combo provides targeted relief by altering pain perception directly at the nervous system level. This could potentially offer more effective pain control with fewer side effects. On the other hand, the paravertebral block with ropivacaine works by delivering a local anesthetic directly near the nerves of the ribs, which may provide superior localized pain relief compared to systemic medications. These approaches could lead to faster recovery and less reliance on opioids, which is a significant advantage in pain management.

What evidence suggests that this trial's treatments could be effective for rib fracture pain?

This trial will compare two treatment options for managing pain from rib fractures: lidocaine and ketamine infusions, and paravertebral blocks with ropivacaine. Research has shown that paravertebral blocks with ropivacaine effectively manage pain from broken ribs, providing strong relief and serving as a reliable alternative to options like epidurals. Early evidence suggests that lidocaine and ketamine infusions are safe and might aid in pain control. Ketamine infusions have been successfully used for rib fracture pain. However, the combination of lidocaine and ketamine for this purpose is still under study, and more information is needed to determine their effectiveness compared to paravertebral blocks. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 hospitalized with rib fractures who haven't had relief from standard pain treatments. It's not for those under 18 or over 80, pregnant women, patients with severe head injuries, spinal cord or serious pelvic injuries, those needing major surgery like laparotomy or thoracotomy during the stay, intubated patients at admission, or prisoners.

Inclusion Criteria

My usual pain management isn't working, and I have severe breathing issues and a weak cough.

Exclusion Criteria

I have had or am expected to have brain surgery during this hospital stay.

I need help with daily activities like eating, dressing, or bathing.

I have had or will have chest surgery during this hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either paravertebral block with ropivacaine or simultaneous ketamine and lidocaine infusions for pain management

1 week

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain scores and opioid usage

1 week

Follow-up assessments post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine and Ketamine Infusions
• N/A
• Paravertebral Block with Ropivacaine

Trial Overview The study compares two methods of pain control in rib fracture patients: a paravertebral block using ropivacaine and infusions of lidocaine and ketamine. The goal is to see if the drug infusions work as well as the nerve block for managing acute pain without being worse.

How Is the Trial Designed?

Group I: lidocaine/ ketamine infusion Active Control 1 Intervention

Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.

Group II: paravertebral block with ropivacaine Active Control 1 Intervention

Paravertebral block catheter will be placed by Anesthesiology led Acute Pain Service. Once the catheter is inserted, a ropivacaine bolus and infused with ropivacaine, monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Published Research Related to This Trial

In a study of 20 noncardiac patients undergoing lung-resection surgery, a 5 mg/kg lidocaine bolus injected into the thoracic paravertebral space resulted in a temporary decrease in myocardial contractility, but overall hemodynamic stability was maintained during one-lung ventilation.

The minor reductions in heart rate and systolic blood pressure observed were self-limiting and did not require any vasoactive drugs, indicating that TPVB can be safely used in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic effects of lidocaine in the thoracic paravertebral space during one-lung ventilation for thoracic surgery. Garutti, I., Olmedilla, L., Pérez-Peña, JM., et al.[2014]

In a study of 60 patients undergoing breast cancer surgery, a paravertebral block (PVB) with bupivacaine significantly reduced postoperative pain and the need for opioid medication by 40%, leading to better pain management and recovery outcomes.

Patients receiving the PVB also experienced less postoperative nausea and vomiting (PONV), improved cognitive function, and less sedation compared to those who received a saline placebo, indicating that PVB enhances recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Kairaluoma, PM., Bachmann, MS., Korpinen, AK., et al.[2022]

In a study of 70 patients undergoing modified radical mastectomy, ropivacaine provided a faster onset of sensory blockade compared to bupivacaine, with 53% of patients achieving adequate sensory blockade within 6 minutes, versus only 20% for bupivacaine.

Ropivacaine not only resulted in a wider and longer-lasting sensory blockade (88% of patients blocking 9 segments compared to 65% with bupivacaine), but also maintained effective analgesia for 24 hours in 81% of patients, compared to 50% for bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory blockade after thoracic paravertebral injection of ropivacaine or bupivacaine. Hura, G., Knapik, P., Misiołek, H., et al.[2018]

A study involving 60 patients undergoing thoracotomy found that using a paravertebral block (PVB) with ropivacaine is a safe and effective method for managing post-thoracotomy pain, with only 11.6% of patients requiring additional pain relief.

The timing of ropivacaine administration (before or after rib spreading) did not significantly affect pain levels, indicating that PVB can be effectively used regardless of when it is administered during the surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of analgesic quality after a thoracotomy: paravertebral block with ropivacaine before and after rib spreading. Fibla, JJ., Molins, L., Mier, JM., et al.[2022]

In a study of 194,766 patients with rib fractures, epidural analgesia (EA) and paravertebral block (PVB) showed no significant differences in clinical outcomes, suggesting both methods are similarly effective for pain management.

Patients who did not receive either EA or PVB had a significantly higher risk of in-hospital mortality (odds ratio: 2.25), indicating that some form of analgesic intervention is crucial for improving survival rates in rib fracture cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Malekpour, M., Hashmi, A., Dove, J., et al.[2018]

In a study of 48 breast cancer surgery patients, using 0.25% bupivacaine combined with fentanyl provided effective post-operative pain relief comparable to 0.5% bupivacaine, while reducing the risk of systemic toxicity.

The combination of lower concentration bupivacaine with fentanyl resulted in significantly less need for rescue analgesics and maintained effective pain control for an average of 18 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative pain and analgesic requirements after paravertebral block for mastectomy: A randomized controlled trial of different concentrations of bupivacaine and fentanyl. Bhuvaneswari, V., Wig, J., Mathew, PJ., et al.[2022]

Continuous thoracic paravertebral block using ropivacaine with adrenaline provides effective analgesia for patients with multiple fractured ribs, with no signs of local anesthetic toxicity observed in the study of 30 adults.

The addition of fentanyl to the ropivacaine infusion allows for a lower concentration of ropivacaine without compromising pain relief or increasing side effects, suggesting a safer and effective pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous paravertebral infusion of ropivacaine with or without fentanyl for pain relief in unilateral multiple fractured ribs. Mohta, M., Ophrii, EL., Sethi, AK., et al.[2021]

A continuous infusion of ropivacaine via a thoracic paravertebral block significantly reduced pain scores at rest and during coughing in postoperative patients compared to a control group, indicating improved pain management.

Patients receiving the ropivacaine infusion experienced fewer side effects, such as nausea and urinary retention, while maintaining safe plasma levels of the drug, suggesting a safer alternative to traditional epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. Marret, E., Bazelly, B., Taylor, G., et al.[2022]

This case study reports the successful use of a paravertebral catheter for continuous ropivacaine infusion in a 76-year-old woman undergoing first rib resection, providing effective postoperative pain control.

The findings suggest that paravertebral catheter infusions could be a beneficial addition to general anesthesia for thoracic surgeries, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T1 Paravertebral Catheter for Postoperative Pain Management After First Rib Resection for Venous Thoracic Outlet Syndrome: A Case Report. Kalava, A., Pribish, AM.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04781673

Ketamine vs Lidocaine in Traumatic Rib Fractures Currently there is no published studies to assess lidocaine's effectiveness to reduce pain scores and opioid use in traumatic rib fracture patients. There is ...

2. clinicaltrial.be clinicaltrial.be/en/details/55484?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

PVB vs Ketamine/Lidocaine in Rib Fracture Patients - Clin... Ketamine and lidocaine infusions are an attractive alternative in these situations, but the data regarding efficacy are lacking. Low dose ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S095281802300226X

Pain management for hospitalized patients with rib fractures This is systematic review of randomized clinical trials evaluating analgesia for rib fracture pain. •. The review found that studies are of low quality with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017257/

Comparison of the analgesic dose of intravenous ketamine ... They demonstrated that ketamine infusion was a safe and appropriate alternative for epidural analgesia for pain control in multiple rib fracture ...

5. ctv.veeva.com ctv.veeva.com/study/pvb-vs-ketamine-lidocaine-in-rib-fracture-patients

PVB vs Ketamine/Lidocaine in Rib Fracture Patients The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39443839/

No benefit from the addition of low-dose ketamine infusion ... A prior study reported decreased pain scores with LDKI in patients with multiple rib fractures. We hypothesized that LDKI would decrease ...

7. withpower.com withpower.com/trial/phase-4-rib-fractures-3-2021-9fff4

Ketamine vs Lidocaine for Rib Fractures · Info for Participants Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of ...