- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308587
Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture
Prospective Evaluation of Intercostal Neuralgia Incidence, Risk Factors, and Outcomes in Patients With Chest Tube Insertion After Traumatic Rib Fractures
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Howard Meng, MD
- Phone Number: 416-480-4864
- Email: howard.meng@sunnybrook.ca
Study Contact Backup
- Name: Lilia Kauistov, PhD
- Phone Number: 416-480-4864
- Email: lilia.kaustov@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Howard Meng, MD
- Phone Number: 416-480-4864
- Email: howard.meng@sunnybrook.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chest tube inserted
Patients with acute traumatic rib fracture/chest injury requiring chest tube insertion
|
Insertion of chest tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
1 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 quality of life using EQ-5D-5L (assesses 5 dimensions, with 1 indicating 'no problems' and 5 indicating 'extreme problems')
|
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 quality of life using Promis 6a Sleep questionnaire (scale 1 to 5, with higher numbers indicating poor outcomes and lower numbers indicating good outcomes)
|
1 and 3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SUN 6775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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