Rib Fracture MultipleRIB PAINNCT03770208
RIB PAIN (Rib Fractures Treated With Parental Analgesia With Infused LidocaiNe)
A study testing Intervention: Lidocaine in people with Rib Fracture Multiple and Pain, Chest, run by Western University, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture Multiple, Pain, Chest, Pain, Acute
- What is being tested?
- Intervention: Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2019to 1 Jun 2022
- Phase
- Interventional
- 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
- All adult patients, 18 years or older, admitted to Victoria Hospital's Trauma Service with two or more traumatic rib fractures.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Ian Ball, MD, 519.685.8500 ext. 71513, Ian.Ball@lhsc.on.ca
Petrease H Patton, MD, MSc, HBSc
About this study
Official title: A Randomized Control Trial of Intravenous Lidocaine for the Management of Traumatic Rib Fractures: a Single Trauma Centre Trial
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.
Read more
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.
Read the detailed description
This trial will use a randomized double blind design. All patients (age 18 or older) diagnosed with two or more traumatic rib fractures requiring hospital admission at Victoria Hospital will be identified at the time of admission by trauma team members and / or ICU research assistants. Patients unable to understand or follow instructions in English or French, and those unable to complete the Visual Analog Scale (VAS) for pain for any reason, will be excluded.
Any physician member of the inpatient trauma service team, trauma nurse practitioner, or ICU research assistants may approach patients and their families to discuss participation in the trial. Research assistants will be responsible for providing the Letter of Information and Consent Form to families, and storing them once complete. Consented patients will be randomized at admission using the online randomization tool, like REDCAP, by pharmacy. Once randomized, research assistants will contact pharmacy to order "Study Drug", but will remain blinded to study arm
Consented patients will receive either standard care (acetaminophen, NSAIDs, opioids) plus IV placebo or standard care plus IV lidocaine using a fixed strategy with variable blocks and a 1:1 allocation ratio. The pharmacy will be the only party unblinded to randomization and will distribute the "Study Drug" [either IV lidocaine or Lactated Ringer's (a clear colourless solution that is indistinguishable from Lidocaine)] to study participants. All patients will be followed throughout their hospital stay by our research assistants to assess pain and secondary outcomes.
IV lidocaine will be administered as a bolus dose of 2 mg/kg (maximum dose 100 mg) followed by a 2 mg/kg/hr infusion for 72-96 hrs. Lactated Ringer's will be administered at the same overall rate to the control group. Patient pain scores will be accessed at the bedside using the VAS at time 0hrs and every six hours for the duration of study drug infusion.
Daily monitoring of the patient will be performed by the trauma team and bedside nurses. Clinical care will be conducted as usual with the exception of the provision of study drug, the recording of pain Q6 hours, and the assessment of patient satisfaction at the end of the 72-96 hour infusion. All other patient data will be collected from the patient's EMR and bedside chart. In accordance with LHSC hospital Lidocaine policy, all study patients will be on telemetry to monitor for arrhythmias resulting from lidocaine toxicity. As the use of IV lidocaine is already common in the LHSC patient population, all nursing staff are trained to detect signs and symptoms of lidocaine toxicity, and will contact the treatment and research teams if these develop. The study drug infusions will be stopped if any signs of toxicity are seen. The treating team will be unblinded to randomization group in any cases of suspected Lidocaine toxicity.
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. 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). Secondary outcomes will be recorded by the ICU research assistants on a daily basis during each patient's index stay. Research assistants will help administer the satisfaction survey to patients as soon as possible following completion of the 72-96 hour Lidocaine infusion. The methodology, pain and satisfaction reporting with VAS is very similar to the investigator's previous work.
A sample size of 26 patients is required to find a difference between two independent group means using the following parameters: (1) a 20% reduction in VAS score (20mm), (2) 90% power, (3) probability of a Type I error = 5%, and s stand deviation of 15% (15mm).
An anticipated attrition rate of 20% will be used to ensure enough patients are included for adequate power. Therefore a minimum of 32 patients will be enrolled in the study.
Continuous data will be reported as mean +/- standard deviation or median and interquartile range, depending on the distribution of each data point. Categorical data will be reported as percentages with corresponding 95% confidence intervals. The mean pain score will be compared between treatment groups using Student's T-test. Findings with a Type I error rate < 5% will be considered statistically significant. Analyses of secondary outcomes will be primarily descriptive. Any significance testing of these outcomes will be strictly hypotheses-generating.
- Conditions
- Rib Fracture Multiple, Pain, Chest, Pain, Acute, Respiratory Failure, Thoracic Injuries, Trauma Chest
- Being tested
- Intervention: Lidocaine, Control: Standard Care + Placebo
- Keywords
- Lidocaine Infusions, Thoracic trauma, Analgesic Management, Rib Fractures, Pain
- Medical subject headings
- Chest Pain, Acute Pain, Respiratory Insufficiency, Thoracic Injuries, Rib Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: LidocaineDrug
Also called Lidocaine Hydrochloride
IV Lidocaine bolus plus infusion. Weight based.
Control: Standard Care + PlaceboDrug
Also called Lactated Ringers, Ringer's Lactate
Placebo IV bolus and infusion. Weight based to mimic lidocaine volume.
| Study group | Role | What they receive |
|---|---|---|
| Control: Standard Care + Placebo | Placebo comparator | Standard care (acetaminophen, NSAIDs, opioids, gabapentin) as directed by MRP care team plus IV placebo (Lactated Ringers). Lactated Ringers will be delivered as a "initial bolus" and then run as a continuous infusion to mimic the volume (as per Kg) of study drug for 72-96 hours. Standard care will be determined by the care team with no limitations introduced by the research team. Medications utilized and dosing regimes will be recorded after the intervention. Receives: Drug: Control: Standard Care + Placebo |
| Intervention: Lidocaine | Experimental | Standard care (acetaminophen, NSAIDs, opioids, gabapentin) as directed by MRP care team plus IV lidocaine. IV lidocaine will be administered as a bolus dose of 2 mg/kg (maximum dose 100 mg) followed by a 2 mg/kg/hr infusion for 72-96 hrs. Receives: Drug: Intervention: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (12)
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Research assistants will help administer the satisfaction survey to patients as soon as possible following completion of the 72-96 hour Lidocaine infusion.
Incidence of respiratory failure requiring mechanical ventilation
Categorical data will be reported as percentages with corresponding 95% confidence intervals.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Incidence of Mortality
Categorical data will be reported as percentages with corresponding 95% confidence intervals.
Measured: 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.
Incidence of lidocaine toxicity/adverse events
Categorical data will be reported as percentages with corresponding 95% confidence intervals. Toxic symptoms will also be recorded.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Dosages
Dosages of any non-opioid analgesic medications used will be recorded.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Frequency
Dosing frequency of any non-opioid analgesic medications used will be recorded.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
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.
Measured: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start6 Jun 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Rib Fracture MultipleStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT, single site, double blinded
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Ball, Western University, Canada
- Investigators
- Ian Ball, MD, MSc (Epi), FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770208
- Sponsor's protocol ID
- PPIB0247S
- Acronym
- RIB PAIN
- Status last verified
- Oct 2019
- First submitted
- 12 Sep 2018
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61.
PubMed 9156291Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PubMed 7996614Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
PubMed 12853057Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.
PubMed 16385313Wu CL, Jani ND, Perkins FM, Barquist E. Thoracic epidural analgesia versus intravenous patient-controlled analgesia for the treatment of rib fracture pain after motor vehicle crash. J Trauma. 1999 Sep;47(3):564-7. doi: 10.1097/00005373-199909000-00025.
PubMed 10498316Carrier FM, Turgeon AF, Nicole PC, Trepanier CA, Fergusson DA, Thauvette D, Lessard MR. Effect of epidural analgesia in patients with traumatic rib fractures: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2009 Mar;56(3):230-42. doi: 10.1007/s12630-009-9052-7. Epub 2009 Feb 11.
PubMed 19247744Linton DM, Potgieter PD. Conservative management of blunt chest trauma. S Afr Med J. 1982 Jun 12;61(24):917-9.
PubMed 7046093Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008 Jun;100(6):747-58. doi: 10.1093/bja/aen094. Epub 2008 May 1.
PubMed 18456641Ruppen W, Derry S, McQuay H, Moore RA. Incidence of epidural hematoma, infection, and neurologic injury in obstetric patients with epidural analgesia/anesthesia. Anesthesiology. 2006 Aug;105(2):394-9. doi: 10.1097/00000542-200608000-00023.
PubMed 16871074Allen DJ, Chae-Kim SH, Trousdale DM. Risks and complications of neuraxial anesthesia and the use of anticoagulation in the surgical patient. Proc (Bayl Univ Med Cent). 2002 Oct;15(4):369-73. doi: 10.1080/08998280.2002.11927867.
PubMed 16333466Karmakar MK, Ho AM. Acute pain management of patients with multiple fractured ribs. J Trauma. 2003 Mar;54(3):615-25. doi: 10.1097/01.TA.0000053197.40145.62.
PubMed 12634549Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.
PubMed 15300210Arendt K, Segal S. Why epidurals do not always work. Rev Obstet Gynecol. 2008 Spring;1(2):49-55.
PubMed 18769661McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
PubMed 20518581Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PubMed 21061107
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Intravenous Lidocaine for the Management of Traumatic Rib Fractures: a Single Trauma Centre Trial
- ClinicalTrials.gov ID
- NCT03770208
- Acronym / sponsor ID
- RIB PAIN / PPIB0247S
- Conditions
- Rib Fracture Multiple, Pain, Chest, Pain, Acute, Respiratory Failure, Thoracic Injuries, Trauma Chest
- Keywords
- Lidocaine Infusions, Thoracic trauma, Analgesic Management, Rib Fractures, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Dec 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.
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.
Detailed description
This trial will use a randomized double blind design. All patients (age 18 or older) diagnosed with two or more traumatic rib fractures requiring hospital admission at Victoria Hospital will be identified at the time of admission by trauma team members and / or ICU research assistants. Patients unable to understand or follow instructions in English or French, and those unable to complete the Visual Analog Scale (VAS) for pain for any reason, will be excluded.
Any physician member of the inpatient trauma service team, trauma nurse practitioner, or ICU research assistants may approach patients and their families to discuss participation in the trial. Research assistants will be responsible for providing the Letter of Information and Consent Form to families, and storing them once complete. Consented patients will be randomized at admission using the online randomization tool, like REDCAP, by pharmacy. Once randomized, research assistants will contact pharmacy to order "Study Drug", but will remain blinded to study arm
Consented patients will receive either standard care (acetaminophen, NSAIDs, opioids) plus IV placebo or standard care plus IV lidocaine using a fixed strategy with variable blocks and a 1:1 allocation ratio. The pharmacy will be the only party unblinded to randomization and will distribute the "Study Drug" [either IV lidocaine or Lactated Ringer's (a clear colourless solution that is indistinguishable from Lidocaine)] to study participants. All patients will be followed throughout their hospital stay by our research assistants to assess pain and secondary outcomes.
IV lidocaine will be administered as a bolus dose of 2 mg/kg (maximum dose 100 mg) followed by a 2 mg/kg/hr infusion for 72-96 hrs. Lactated Ringer's will be administered at the same overall rate to the control group. Patient pain scores will be accessed at the bedside using the VAS at time 0hrs and every six hours for the duration of study drug infusion.
Daily monitoring of the patient will be performed by the trauma team and bedside nurses. Clinical care will be conducted as usual with the exception of the provision of study drug, the recording of pain Q6 hours, and the assessment of patient satisfaction at the end of the 72-96 hour infusion. All other patient data will be collected from the patient's EMR and bedside chart. In accordance with LHSC hospital Lidocaine policy, all study patients will be on telemetry to monitor for arrhythmias resulting from lidocaine toxicity. As the use of IV lidocaine is already common in the LHSC patient population, all nursing staff are trained to detect signs and symptoms of lidocaine toxicity, and will contact the treatment and research teams if these develop. The study drug infusions will be stopped if any signs of toxicity are seen. The treating team will be unblinded to randomization group in any cases of suspected Lidocaine toxicity.
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. 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). Secondary outcomes will be recorded by the ICU research assistants on a daily basis during each patient's index stay. Research assistants will help administer the satisfaction survey to patients as soon as possible following completion of the 72-96 hour Lidocaine infusion. The methodology, pain and satisfaction reporting with VAS is very similar to the investigator's previous work.
A sample size of 26 patients is required to find a difference between two independent group means using the following parameters: (1) a 20% reduction in VAS score (20mm), (2) 90% power, (3) probability of a Type I error = 5%, and s stand deviation of 15% (15mm).
An anticipated attrition rate of 20% will be used to ensure enough patients are included for adequate power. Therefore a minimum of 32 patients will be enrolled in the study.
Continuous data will be reported as mean +/- standard deviation or median and interquartile range, depending on the distribution of each data point. Categorical data will be reported as percentages with corresponding 95% confidence intervals. The mean pain score will be compared between treatment groups using Student's T-test. Findings with a Type I error rate < 5% will be considered statistically significant. Analyses of secondary outcomes will be primarily descriptive. Any significance testing of these outcomes will be strictly hypotheses-generating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- RCT, single site, double blinded
| Arm | Type | Receives |
|---|---|---|
| Control: Standard Care + Placebo | Placebo comparator | Drug: Control: Standard Care + PlaceboStandard care (acetaminophen, NSAIDs, opioids, gabapentin) as directed by MRP care team plus IV placebo (Lactated Ringers). Lactated Ringers will be delivered as a "initial bolus" and then run as a continuous infusion to mimic the volume (as per Kg) of study drug for 72-96 hours. Standard care will be determined by the care team with no limitations introduced by the research team. Medications utilized and dosing regimes will be recorded after the intervention. |
| Intervention: Lidocaine | Experimental | Drug: Intervention: LidocaineStandard care (acetaminophen, NSAIDs, opioids, gabapentin) as directed by MRP care team plus IV lidocaine. IV lidocaine will be administered as a bolus dose of 2 mg/kg (maximum dose 100 mg) followed by a 2 mg/kg/hr infusion for 72-96 hrs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients, 18 years or older, admitted to Victoria Hospital's Trauma Service with two or more traumatic rib fractures.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Intervention: LidocaineAlso: Lidocaine HydrochlorideIV Lidocaine bolus plus infusion. Weight based. | Drug | Intervention: Lidocaine |
| Control: Standard Care + PlaceboAlso: Lactated Ringers, Ringer's LactatePlacebo IV bolus and infusion. Weight based to mimic lidocaine volume. | Drug | Control: Standard Care + Placebo |
Primary outcome
Mean Visual Analogue Scale (VAS) Score for Pain
Time frame: Pain score to be measured before treatment initiation and every 6 hours thereafter until 72-96 hours. Scores will be performed by bedside nursing.
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.
12 secondary outcomes
Incidence of Protocol Non-adherence
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Patient satisfaction as measured on the Visual Analogue Scale for Satisfaction
Time frame: Research assistants will help administer the satisfaction survey to patients as soon as possible following completion of the 72-96 hour Lidocaine infusion.
Incidence of respiratory failure requiring mechanical ventilation
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Hospital length of stay
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
ICU length of stay
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Incidence of Mortality
Time frame: 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.
Incidence of lidocaine toxicity/adverse events
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Medication type
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Dosages
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Frequency
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Treatment regimens (use of additional non-opioid analgesics): Delivery Route
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Total morphine equivalents used (including breakthrough doses)
Time frame: Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Background: PubMed 9156291Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61.
- Background: PubMed 7996614Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
- Background: PubMed 12853057Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
- Background: PubMed 16385313Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.
- Background: PubMed 10498316Wu CL, Jani ND, Perkins FM, Barquist E. Thoracic epidural analgesia versus intravenous patient-controlled analgesia for the treatment of rib fracture pain after motor vehicle crash. J Trauma. 1999 Sep;47(3):564-7. doi: 10.1097/00005373-199909000-00025.
- Background: PubMed 19247744Carrier FM, Turgeon AF, Nicole PC, Trepanier CA, Fergusson DA, Thauvette D, Lessard MR. Effect of epidural analgesia in patients with traumatic rib fractures: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2009 Mar;56(3):230-42. doi: 10.1007/s12630-009-9052-7. Epub 2009 Feb 11.
- Background: PubMed 7046093Linton DM, Potgieter PD. Conservative management of blunt chest trauma. S Afr Med J. 1982 Jun 12;61(24):917-9.
- Background: PubMed 18456641Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008 Jun;100(6):747-58. doi: 10.1093/bja/aen094. Epub 2008 May 1.
- Background: PubMed 16871074Ruppen W, Derry S, McQuay H, Moore RA. Incidence of epidural hematoma, infection, and neurologic injury in obstetric patients with epidural analgesia/anesthesia. Anesthesiology. 2006 Aug;105(2):394-9. doi: 10.1097/00000542-200608000-00023.
- Background: PubMed 16333466Allen DJ, Chae-Kim SH, Trousdale DM. Risks and complications of neuraxial anesthesia and the use of anticoagulation in the surgical patient. Proc (Bayl Univ Med Cent). 2002 Oct;15(4):369-73. doi: 10.1080/08998280.2002.11927867.
- Background: PubMed 12634549Karmakar MK, Ho AM. Acute pain management of patients with multiple fractured ribs. J Trauma. 2003 Mar;54(3):615-25. doi: 10.1097/01.TA.0000053197.40145.62.
- Background: PubMed 15300210Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.
- 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.
Ian Ball, MD, MSc (Epi), FRCPC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Lidocaine in people with Rib Fracture Multiple and Pain, Chest, run by Western University, Canada at 1 site in Canada.
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 10 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Ball, MD, MSc (Epi), FRCPC (519.685.8500 ext. 71513, Ian.Ball@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Visual Analogue Scale (VAS) Score for Pain (time frame: Pain score to be measured before treatment initiation and every 6 hours thereafter until 72-96 hours. Scores will be performed by bedside nursing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770208, which also lists 19 linked publications.
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 8 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.