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Recruiting NCT07308587

Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture

Observational Intercostal Nerve Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chest tube insertion.
Who it may be relevant to
Registry conditions: Intercostal Nerve Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Evaluation of Intercostal Neuralgia Incidence, Risk Factors, and Outcomes in Patients With Chest Tube Insertion After Traumatic Rib Fractures

Overview

Traumatic rib fractures are common injuries following blunt chest trauma, often requiring chest tube insertion to manage complications such as pneumothorax or haemothorax. However, chest tube placement can lead to intercostal nerve injury, resulting in intercostal neuralgia-a debilitating condition characterized by chronic, neuropathic pain along the intercostal nerves. Despite its clinical significance, the incidence, risk factors, and long-term outcomes of intercostal neuralgia in this patient population remain poorly understood. Chronic pain following thoracic trauma, including intercostal neuralgia, has been shown to significantly impair quality of life and functional outcomes, leading to prolonged disability and increased healthcare utilization. Current literature highlights the need for better understanding and management of this condition, particularly in patients undergoing invasive procedures such as chest tube insertion. This study aims to prospectively evaluate the development of intercostal neuralgia in patients with chest tube insertion following traumatic rib fractures.

Detailed description

Intercostal neuralgia is defined as pain along the intercostal nerve distribution with neuropathic features. Chronic intercostal neuralgia is defined as having intercostal neuralgia symptoms for \>3 months.

Intercostal neuralgia pain will be specifically differentiated from persistent rib fracture pain through the presence of neuropathic pain at the level of the chest tube/pigtail that is reproducible with brushing/light touch to the chest tube scar site.

The following data will be collected:

Baseline:

* Demographic information (age, sex, ethnicity, comorbidities). * Pain assessment using numerical rating scale at rest and with deep inspiration * Pre-existing chronic pain conditions (e.g., fibromyalgia, chronic regional pain syndrome) and history of prior thoracic surgery or chest tube insertion. * Injury characteristics (mechanism of injury including presence of foreign bodies and additional penetrating injuries, number and location of rib fractures, associated injuries including vertebral body fractures, sternal fracture, transverse process fracture). * Neurologic assessment (Glasgow Coma Scale \[GCS\] on presentation and at time of recruitment) * Brain imaging findings on presentation (if applicable) * Chest tube / pigtail details (size, insertion site, duration of placement). * Spirometry testing including forced vital capacity (FVC) and forced expiratory volume (FEV1) at time of enrolment of study

Additional information to be collected following hospital stay:

* Analgesic use including dose of opioids, use of regional anesthesia techniques, and adjunct analgesic medications while in hospital * Length of hospital stay * Presence and duration of mechanical ventilation * Number of surgeries

Follow ups: 1 (± 3 days) and 3 months (± 1 week) via telephone

* Pain assessment using the numerical rating scale at rest and with deep inspiration * Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) for neuropathic pain * EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) for health related quality of life * Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance 6a for sleep * Medication use (analgesics, neuropathic pain medications) * Neurologic assessment at discharge (GCS, diagnosis of traumatic brain injury) * Brain imaging findings on presentation (if applicable)

Patients who are found to have intercostal neuralgia at 3 month follow up assessment can be referred to the pain clinic and choose to be sent for formal ultrasound to identify and characterize findings to indicate the presence of neuroma (a non-cancerous tumor or growth of nerve tissue), degree of scarring, or any other pain generating causes, if agreed. Participants' preferences regarding the disclosure of neuroma, including their right to know or not to know, will be respected (as described in the consent form).

Interventions

  • Procedure Chest tube insertion
    Insertion of chest tube

Primary outcome measures

  • Incidence of intercostal neuralgia [Time frame: 1 and 3 months]
Secondary outcome measures (3)
  • Assess the impact of intercostal neuralgia on quality of life and functional outcomes [Time frame: 1 and 3 months]
  • Assess the impact of intercostal neuralgia on quality of life and functional outcomes [Time frame: 1 and 3 months]
  • Assess the impact of intercostal neuralgia on medication use [Time frame: 1 and 3 months]

Eligibility criteria

Inclusion criteria

  • Adults (≥18 years) with traumatic rib fractures requiring chest tube insertion
  • Chest tube or pigtail insertion performed during their initial hospitalization for trauma

Exclusion criteria

  • Patients with spinal cord injury
  • Inability to complete follow-up assessments (e.g., language barriers, lack of telephone access)

Exclusion criteria

  • Patients with traumatic brain injury
  • Patients with spinal cord injury
  • Inability to complete follow-up assessments (e.g., language barriers, lack of telephone access)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto

Publications

  • Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007. PMID 10866248
  • 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
  • Bailey RC. Complications of tube thoracostomy in trauma. J Accid Emerg Med. 2000 Mar;17(2):111-4. doi: 10.1136/emj.17.2.111. PMID 10718232
  • Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007. PMID 23592156
  • Blyth FM, March LM, Brnabic AJ, Cousins MJ. Chronic pain and frequent use of health care. Pain. 2004 Sep;111(1-2):51-8. doi: 10.1016/j.pain.2004.05.020. PMID 15327808

Identifiers

NCT: NCT07308587 · SUN 6775

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗