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NCT Number: NCT07308587

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Howard Meng, MD

CONTACT

[email protected]

416-480-4864

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chest tube insertion

Procedure

Insertion of chest tube

Primary outcomes

  1. Incidence of intercostal neuralgia

    Time frame: 1 and 3 months

    To determine the incidence of intercostal neuralgia in patients undergoing chest tube insertion after traumatic rib fractures. Presence of neuropathic pain to be assessed using S-LANSS (score of 12 or more suggests pain of predominantly neuropathic origin)

Secondary outcomes

  1. 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 using EQ-5D-5L (assesses 5 dimensions, with 1 indicating 'no problems' and 5 indicating 'extreme problems')

  2. 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 using Promis 6a Sleep questionnaire (scale 1 to 5, with higher numbers indicating poor outcomes and lower numbers indicating good outcomes)

  3. Assess the impact of intercostal neuralgia on medication use

    Time frame: 1 and 3 months

    Determine the impact of intercostal neuralgia on medication use including opioids and anti-neuropathic medications by collection and assessment of quantity of medications taken for pain relief related to intercostal neuralgia.

Study contacts

Contact information is provided by the study sponsor or research team.

Howard Meng, MD

CONTACT

[email protected]

416-480-4864

Lilia Kauistov, PhD

CONTACT

[email protected]

416-480-4864

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.