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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
Failure of standard pain regimen as determined by RR > 20, TV ≤ 50% predicted, NPS ≥ 5, Poor cough
Timeline
Screening 3 weeks
Treatment Varies
Follow Up captured after patient is discharged, an average of 1 week
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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My usual pain management isn't working, and I have severe breathing issues and a weak cough.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Pain Score (NPS)
Oral Morphine Equivalence (OME)
Secondary outcome measures
Hospital Length of Stay (LOS)
ICU Length of Stay (ICU LOS)
disposition upon discharge
+3 more

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.

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,529 Total Patients Enrolled

Media Library

Lidocaine and Ketamine Infusions (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04413799 — Phase < 1
Rib Fractures Research Study Groups: lidocaine/ ketamine infusion, paravertebral block with ropivacaine
Rib Fractures Clinical Trial 2023: Lidocaine and Ketamine Infusions Highlights & Side Effects. Trial Name: NCT04413799 — Phase < 1
Lidocaine and Ketamine Infusions (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04413799 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still enrolling participants?

"According to clinicaltrials.gov, this medical study commenced recruitment on September 1st 2020 and is still in need of patients with the most recent edit occurring on April 27th 2022."

Answered by AI

Have any prior studies been conducted regarding lidocaine/ ketamine infusions?

"Presently, 273 studies are investigating the efficacy of lidocaine/ ketamine infusion. Of those trials, 61 have progressed to Phase 3 evaluations. While most investigations are based in Duarte, California, 1323 sites worldwide offer this treatment trial as an option for their patients."

Answered by AI

What are the typical applications for lidocaine/ ketamine infusions?

"Lidocaine/ ketamine infusion can be utilized to address cervical syndrome, minor burns, and general anesthesia."

Answered by AI

What is the uppermost limit of individuals enrolled in this experiment?

"Affirmative, the information on clinicaltrials.gov indicates that this medical research is currently recruiting individuals. It was initially posted in September of 2020 and has been recently modified in April 2022; 170 participants are desired from a single site."

Answered by AI

What are the fundamental goals of this clinical experiment?

"The primary purpose of this trial, which will be monitored over the span of a typical inpatient hospital stay (one week), is to measure Oral Morphine Equivalence (OME). Secondary objectives include assessing the incidence of pneumonia via diagnosis by attending medical personnel, tracking patient disposition after discharge such as home care or long-term acute facility stays, and monitoring in-hospital mortality."

Answered by AI

Is this medical experiment open to minors?

"To be eligible for this medical study, applicants must between 18 and 80 years old. There are 118 trials specifically targeting minors and 614 aimed at individuals over the age of 65."

Answered by AI

Are my qualifications sufficient to join this experimental undertaking?

"This research is seeking 170 qualified volunteers between 18 and 80 of age, with rib fractures causing acute pain. Furthermore, potential participants must have been admitted to a hospital for treatment related to their injury."

Answered by AI
~30 spots leftby Dec 2024