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N/A

Lidocaine + Ketamine vs Paravertebral Block for Rib Fractures

Phase < 1

Recruiting

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80 with rib fracture requiring hospitalization

Be older than 18 years old

Must not have

Prior or expected emergent craniotomy during this admission

Inability to accomplish activities of daily living independently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up captured after patient is discharged, an average of 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a lidocaine and ketamine infusion to control pain from rib fractures is non-inferior to the current standard of care, which is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to medications used (ropivacaine, lidocaine, ketamine), potential nerve damage from the paravertebral block procedure, dizziness, nausea from drugs infusion and changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have had or will need surgery for a pelvic injury.

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I was on a breathing machine when I was admitted to the hospital.

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I am over 80 years old.

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I am expected to or have had exploratory surgery in my abdomen during this hospital stay.

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My consciousness level is moderately impaired.

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I have a spinal cord injury.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ captured after patient is discharged, an average of 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~captured after patient is discharged, an average of 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and captured after patient is discharged, an average of 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numeric Pain Score (NPS)

Oral Morphine Equivalence (OME)

Secondary study objectives

Hospital Length of Stay (LOS)

ICU Length of Stay (ICU LOS)

disposition upon discharge

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met