Recruiting

Lidocaine

Sponsor:

Western University, Canada

Code:

NCT03770208

Conditions

Rib Fracture Multiple

Pain, Chest

Pain, Acute

Respiratory Failure

Thoracic Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention: Lidocaine

Control: Standard Care + Placebo

Study Details

Brief 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. 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.

Conditions

Rib Fracture Multiple

Pain, Chest

Pain, Acute

Respiratory Failure

Thoracic Injuries

Study ID

NCT03770208

Start date

Jun 6, 2019

Status verified date

Oct, 2019

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control: Standard Care + Placebo

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.

experimental: Intervention: Lidocaine

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.

Interventions

Intervention: Lidocaine

IV Lidocaine bolus plus infusion. Weight based.

Control: Standard Care + Placebo

Placebo IV bolus and infusion. Weight based to mimic lidocaine volume.

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. ]

Central Contacts and Locations

Central contacts

Ian Ball, MD, MSc (Epi), FRCPC

519.685.8500Ian.Ball@lhsc.on.ca

Locations

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Ian Ball, MD

519.685.8500Ian.Ball@lhsc.on.ca

Principal Investigator:

Ian Ball, MD, MSc, FRCPC

More Information

Sponsor

Western University, Canada

Last update posted

Oct 8, 2019

Last verified

Oct, 2019

Keywords

  • Lidocaine Infusions
  • Thoracic trauma
  • Analgesic Management
  • Rib Fractures
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2019-10-08.