Respiratory Failure Clinical Trial
— RIB PAINOfficial title:
A Randomized Control Trial of Intravenous Lidocaine for the Management of Traumatic Rib Fractures: a Single Trauma Centre Trial
NCT number | NCT03770208 |
Other study ID # | PPIB0247S |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2019 |
Est. completion date | June 1, 2022 |
Traumatic rib fractures (RF) are a relatively common occurrence in patients of all ages, with
a 10% incidence in all trauma patients and are associated with significant morbidity and
mortality. Adequate analgesia is paramount for preventing pulmonary complications and can
reduce morbidity and mortality. There is longstanding evidence of lidocaine's effectiveness
and safety in the post-operative patient and the investigators hypothesize that this modality
may prove to be ideal in trauma patients with RF. Therefore, it is imperative that
intravenous lidocaine be investigated to ascertain if there is significant benefit for pain
reduction in patients who have sustained rib fractures.
A single-centre, double-blind, randomized control trial to evaluate the analgesic efficacy of
a 72-96 hour IV lidocaine infusion plus standard analgesics versus placebo infusion plus
standard analgesics will be performed on patients (age 18 or older) diagnosed with two or
more traumatic rib fractures ,from blunt thoracic trauma, requiring hospital admission at
Victoria Hospital.
The primary outcome is mean pain score, as measured on the Visual Analog Scale (VAS) when the
patient is at rest and with movement. Secondary outcomes are protocol adherence, patient
satisfaction as measured on the VAS, incidence of respiratory failure requiring mechanical
ventilation, hospital length of stay, ICU length of stay, mortality, incidence of lidocaine
toxicity, treatment regimens (use of additional non-opioid analgesics) and total morphine
equivalents used (including breakthrough doses).
This trial will serve to quantify the analgesic efficacy of intravenous lidocaine for
patients with traumatic rib fractures. Successful completion of a single centre trial will
inform the development of a multi-centre trial powered to demonstrate a reduction in
respiratory failure in the trauma population.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | June 1, 2022 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients, 18 years or older, admitted to Victoria Hospital's Trauma Service with two or more traumatic rib fractures. Exclusion Criteria: - Patients under 18 years old - Patients who sustained complex trauma with multiple other injuries or have decreased LOC or required intubation at admission - Patients with a known allergy/sensitivity to Lidocaine or other local anesthetic, amide anesthetics or components of the solution - Patients with a known history of hypersensitivity to methylparaben and/or propylparaben (preservatives used in multidose solutions), or to their metabolite para amino benzoic acid - Patients who do not speak English with adequate fluency to consent or participate in the VAS survey - Patients receiving epidural analgesia for another reason - Patients with pre-existing cardiac arrhythmias including Adam-Stokes syndrome; Wolff- Parkinson-White syndrome; and severe degrees of sinoatrial, atrioventricular, or intraventricular heart block (except in patients with a functioning artificial pacemaker) - Patients who are known to be pregnant or breast feeding, as identified on Past Medical History, or by initial laboratory investigations performed as a part of standard trauma team assessment - Patients with known hepatic/renal disease, as identified on Past Medical History, or by initial laboratory investigations performed as a part of standard trauma team assessment - Patients who refuse inclusion |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre - Victoria Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Visual Analogue Scale (VAS) Score for Pain | The primary outcome will be mean pain score calculated from the multiple VAS measures performed during Lidocaine infusions when the patient is at rest and with movement. The VAS for pain is a continuous numerical scale, demonstrated by a horizontal or vertical line, 10 cm long, with verbal descriptors at each end demonstrating the extremes, +/- a central descriptor. It is a scale essentially from 1 to 10, with one being no pain and 10 being the worst pain possible. Subjects mark on the line their approximate pain score by drawing a transecting line. This will be measured with a ruler from the start point on the line and recorded as a data point. | Pain score to be measured before treatment initiation and every 6 hours thereafter until 72-96 hours. Scores will be performed by bedside nursing. | |
Secondary | Incidence of Protocol Non-adherence | Incidence of protocol violations with corresponding 95% confidence intervals. Descriptions of the deviations will be recorded. Types include, number of patients who received lidocaine that were not assigned to that group; number of patients who were assigned lidocaine and never received the study drug; non-weight based dosages of lidocaine; etc. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Patient satisfaction as measured on the Visual Analogue Scale for Satisfaction | The VAS for pain is a continuous numerical scale, demonstrated by a horizontal or vertical line, 10 cm long, with verbal descriptors at each end demonstrating the extremes, +/- a central descriptor. It is measured from one, representing not satisfied at all to ten, representing completely satisfied. Subjects mark on the line their approximate pain score by drawing a transecting line. This will be measured with a ruler from the start point on the line and recorded as a data point. Score will be performed on a VAS at the end of the treatment period. | Research assistants will help administer the satisfaction survey to patients as soon as possible following completion of the 72-96 hour Lidocaine infusion. | |
Secondary | Incidence of respiratory failure requiring mechanical ventilation | Categorical data will be reported as percentages with corresponding 95% confidence intervals. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Hospital length of stay | Continuous data will be reported as mean +/- standard deviation or median and interquartile range, depending on the distribution of each data point. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | ICU length of stay | Continuous data will be reported as mean +/- standard deviation or median and interquartile range, depending on the distribution of each data point. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Incidence of Mortality | Categorical data will be reported as percentages with corresponding 95% confidence intervals. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period or when the mortality occurs. | |
Secondary | Incidence of lidocaine toxicity/adverse events | Categorical data will be reported as percentages with corresponding 95% confidence intervals. Toxic symptoms will also be recorded. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Treatment regimens (use of additional non-opioid analgesics): Medication type | Any non-opioid analgesic medications used will be recorded. Incidence of each medications' use will be reported as percentages with corresponding 95% confidence intervals. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Treatment regimens (use of additional non-opioid analgesics): Dosages | Dosages of any non-opioid analgesic medications used will be recorded. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Treatment regimens (use of additional non-opioid analgesics): Frequency | Dosing frequency of any non-opioid analgesic medications used will be recorded. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Treatment regimens (use of additional non-opioid analgesics): Delivery Route | Route of delivery of any non-opioid analgesic medications used will be recorded. Categories include by mouth (PO); subcutaneously (SubQ); Intravenously (IV); and other. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. | |
Secondary | Total morphine equivalents used (including breakthrough doses) | Dose will be the cumulative opioid dose over the 72-96 hour period. Conversion to Morphine Equivalents will be calculated. Continuous data will be reported as mean +/- standard deviation or median and interquartile range, depending on the distribution of each data point. | Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period. |
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