RIB PAIN (Rib Fractures Treated With Parental Analgesia With Infused LidocaiNe)

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University, Canada
• Treatments: Lidocaine

Criteria

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