170 Participants Needed

Lidocaine + Ketamine vs Paravertebral Block for Rib Fractures

TB
SK
Overseen BySusan Kartiko, MD PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: George Washington University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.

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.

What data supports the effectiveness of the treatment Lidocaine + Ketamine vs Paravertebral Block for Rib Fractures?

Research shows that paravertebral block with ropivacaine is effective for pain relief after surgeries involving the ribs, such as thoracotomy and rib resection, suggesting it could be beneficial for rib fractures as well.12345

Is the combination of Lidocaine and Ketamine or Paravertebral Block with Ropivacaine safe for treating rib fractures?

Paravertebral Block with Ropivacaine has been studied for pain relief in various surgeries and conditions, showing it can be effective and generally safe, though high doses may risk local anesthetic toxicity. Adjusting doses or combining with other drugs like fentanyl can help reduce this risk.12467

How does the treatment of Lidocaine + Ketamine infusions compare to Paravertebral Block with Ropivacaine for rib fractures?

The treatment using Lidocaine and Ketamine infusions is unique because it combines two drugs that work together to manage pain, potentially offering a different mechanism of action compared to the Paravertebral Block with Ropivacaine, which involves injecting a local anesthetic near the spine to block pain from the ribs. This approach may provide an alternative for patients who cannot receive or do not respond well to traditional nerve blocks.12489

Eligibility Criteria

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

I am between 18 and 80 years old and hospitalized due to a broken rib.
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.
See 9 more

Timeline

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

Treatment Details

Interventions

  • Lidocaine and Ketamine Infusions
  • N/A
  • Paravertebral Block with Ropivacaine
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Group I: lidocaine/ ketamine infusionActive Control1 Intervention
Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.
Group II: paravertebral block with ropivacaineActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

Findings from Research

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

References

A prospective study of analgesic quality after a thoracotomy: paravertebral block with ropivacaine before and after rib spreading. [2022]
Post-operative pain and analgesic requirements after paravertebral block for mastectomy: A randomized controlled trial of different concentrations of bupivacaine and fentanyl. [2022]
Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. [2022]
Continuous paravertebral infusion of ropivacaine with or without fentanyl for pain relief in unilateral multiple fractured ribs. [2021]
T1 Paravertebral Catheter for Postoperative Pain Management After First Rib Resection for Venous Thoracic Outlet Syndrome: A Case Report. [2018]
Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. [2022]
Sensory blockade after thoracic paravertebral injection of ropivacaine or bupivacaine. [2018]
Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? [2018]
Hemodynamic effects of lidocaine in the thoracic paravertebral space during one-lung ventilation for thoracic surgery. [2014]