Rib Fracture MultiplePhase 4LidocareNCT03571919
Lidocaine Infusions for Rib Fractures
A Phase 4 study testing Lidocaine infusion and Saline infusion in people with Rib Fracture Multiple and Trauma Chest, run by Stanford University at 1 site in United States.
Trial summary
Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture Multiple, Trauma Chest, Pain, Acute
- What is being tested?
- Lidocaine infusion and Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 1 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older with 2+ rib fractures or > 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI > 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)
Who cannot join
- Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS < 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR < 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic
- Enrollment in other study that may affect the results of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94304
About this study
Official title: Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.
- Conditions
- Rib Fracture Multiple, Trauma Chest, Pain, Acute
- Being tested
- Lidocaine infusion, Saline infusion
- Keywords
- Lidocaine infusion
- Medical subject headings
- Thoracic Injuries, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine infusionDrug
Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
Saline infusionDrug
Intravenous bolus of saline and then infusion
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Will receive normal saline bolus and infusion and have sham lab draws every 8 hours. Receives: Drug: Saline infusion |
| Lidocaine | Active comparator | Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours. Receives: Drug: Lidocaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid pain medicine usage
Total opioid pain medicine usage
Measured: Average per 24 hours
Secondary outcomes (6)
PCA requirements
Percentage of patients requiring PCA
Measured: 5 days
Pain score
Average pain scores
Measured: 5 days
Length of stay
Average length of stay in ICU and hospital
Measured: 5 days
Respiratory failure
Rates of pneumonia or other respiratory failure (pneumonia defined as (1) new pulmonary infiltrate on chest X-ray and (2) two of three of the following: (a) productive cough (b) WBC > 12,000 and (c) temperature > 38.0)
Measured: 5 days
Death
Mortality rate between two groups
Measured: up to 30 days
Mobility
Highest level of mobility on hospital day #2
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start15 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Why it stopped: Inability to recruit during the Covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib Fracture MultipleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Choi, MD, Principal investigator, Stanford UniversityMichael Y Lin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571919
- Sponsor's protocol ID
- 44300
- Acronym
- Lidocare
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2018
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
- ClinicalTrials.gov ID
- NCT03571919
- Acronym / sponsor ID
- Lidocare / 44300
- Conditions
- Rib Fracture Multiple, Trauma Chest, Pain, Acute
- Keywords
- Lidocaine infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit during the Covid pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Saline infusionWill receive normal saline bolus and infusion and have sham lab draws every 8 hours. |
| Lidocaine | Active comparator | Drug: Lidocaine infusionWill receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 or older with 2+ rib fractures or > 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI > 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)
Key exclusion criteria (2 listed)
- Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS < 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR < 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic
- Enrollment in other study that may affect the results of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine infusionIntravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr | Drug | Lidocaine |
| Saline infusionIntravenous bolus of saline and then infusion | Drug | Control |
Primary outcome
Opioid pain medicine usage
Time frame: Average per 24 hours
Total opioid pain medicine usage
6 secondary outcomes
PCA requirements
Time frame: 5 days
Pain score
Time frame: 5 days
Length of stay
Time frame: 5 days
Respiratory failure
Time frame: 5 days
Death
Time frame: up to 30 days
Mobility
Time frame: 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Choi, MD principal investigator
Stanford University
Michael Y Lin, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine infusion and Saline infusion in people with Rib Fracture Multiple and Trauma Chest, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid pain medicine usage (time frame: Average per 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.