Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture
NCT ID: NCT07308587
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
* 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
* S-LANSS for neuropathic pain
* EQ-5D-5L for health related quality of life
* PROMIS sleep disturbance 6a for sleep
* Medication use (analgesics, neuropathic pain medications)
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chest tube inserted
Patients with acute traumatic rib fracture/chest injury requiring chest tube insertion
Chest tube insertion
Insertion of chest tube
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chest tube insertion
Insertion of chest tube
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* Patients with traumatic brain injury
* Patients with spinal cord injury
* Inability to complete follow-up assessments (e.g., language barriers, lack of telephone access)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUN 6775
Identifier Type: -
Identifier Source: org_study_id