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

NCT03770208 | Unknown

• 1 other identifier: PPIB0247S
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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; Trauma Chest

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Incidence of Protocol Non-adherence

  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

  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

  Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.

• Hospital length of stay

  Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.

• ICU length of stay

  Will be recorded by the ICU research assistants at the end of each patient's 72-96 hour study period.

Study Arms (2)

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.

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.

Drug: Intervention: Lidocaine

Interventions

Intervention: Lidocaine DRUG

IV Lidocaine bolus plus infusion. Weight based.

Also known as: Lidocaine Hydrochloride

Intervention: Lidocaine

Control: Standard Care + Placebo DRUG

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

Also known as: Lactated Ringers, Ringer's Lactate

Control: Standard Care + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients, 18 years or older, admitted to Victoria Hospital's Trauma Service with two or more traumatic rib fractures.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (19)

• Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61.

  PMID: 9156291 BACKGROUND

• Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.

  PMID: 7996614 BACKGROUND

• Sirmali 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.

  PMID: 12853057 BACKGROUND

• Simon 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.

  PMID: 16385313 BACKGROUND

• Wu 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.

  PMID: 10498316 BACKGROUND

• Carrier 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.

  PMID: 19247744 BACKGROUND

• Linton DM, Potgieter PD. Conservative management of blunt chest trauma. S Afr Med J. 1982 Jun 12;61(24):917-9.

  PMID: 7046093 BACKGROUND

• Pattinson 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.

  PMID: 18456641 BACKGROUND

• Ruppen 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.

  PMID: 16871074 BACKGROUND

• Allen 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.

  PMID: 16333466 BACKGROUND

• Karmakar 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.

  PMID: 12634549 BACKGROUND

• Bulger 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.

  PMID: 15300210 BACKGROUND

• Arendt K, Segal S. Why epidurals do not always work. Rev Obstet Gynecol. 2008 Spring;1(2):49-55.

  PMID: 18769661 BACKGROUND

• McCarthy 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.

  PMID: 20518581 BACKGROUND

• Vigneault 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.

  PMID: 21061107 BACKGROUND

• Daykin H. The efficacy and safety of intravenous lidocaine for analgesia in the older adult: a literature review. Br J Pain. 2017 Feb;11(1):23-31. doi: 10.1177/2049463716676205. Epub 2016 Oct 24.

  PMID: 28386401 BACKGROUND

• Nguyen M, Vandenbroucke F, Roy JD, Beaulieu D, Seal RF, Lapointe R, Dagenais M, Roy A, Massicotte L. Evaluation of the addition of bupivacaine to intrathecal morphine and fentanyl for postoperative pain management in laparascopic liver resection. Reg Anesth Pain Med. 2010 May-Jun;35(3):261-6. doi: 10.1097/AAP.0b013e3181de12e4.

  PMID: 20921837 BACKGROUND

• Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.

  PMID: 11331334 BACKGROUND

• Ball IM, Seabrook J, Desai N, Allen L, Anderson S. Dilute proparacaine for the management of acute corneal injuries in the emergency department. CJEM. 2010 Sep;12(5):389-96. doi: 10.1017/s1481803500012537.

  PMID: 20880433 BACKGROUND

MeSH Terms

Conditions

Chest Pain; Acute Pain; Respiratory Insufficiency; Thoracic Injuries; Rib Fractures; Pain

Interventions

Lidocaine; Ringer's Lactate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ian Ball, MD, MSc (Epi), FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Ball, MD, MSc (Epi), FRCPC

CONTACT

519.685.8500; Ian.Ball@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All parties involved until the end of trial. Pharmacy will be the only unblinded party as they need to prepare the study drugs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Critical Care Western Research and Scholar Program Director; Consultant, Critical Care Medicine; Assistant Professor, Department of Medicine and Department of Epidemiology & Biostatistics

Model Details: RCT, single site, double blinded

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: December 10, 2018
• Study Start: June 6, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2022
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)