Intercostal Nerve InjuryNCT07308587
Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture
An observational study of Intercostal Nerve Injury, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intercostal Nerve Injury
- What is being tested?
- Chest tube insertion
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute traumatic rib fractures requiring chest tube insertion for management.
Who may be able to join
- Adults (≥18 years) with traumatic rib fractures requiring chest tube insertion
- Chest tube or pigtail insertion performed during their initial hospitalization for trauma
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Howard Meng, MD, 416-480-4864, howard.meng@sunnybrook.ca
About this study
Official title: 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.
Read the 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).
- Conditions
- Intercostal Nerve Injury
- Being tested
- Chest tube insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube insertionProcedure or surgery
Insertion of chest tube
| Study group | Role | What they receive |
|---|---|---|
| Chest tube inserted | Patients with acute traumatic rib fracture/chest injury requiring chest tube insertion Receives: Procedure: Chest tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intercostal neuralgia
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)
Measured: 1 and 3 months
Secondary outcomes (3)
Assess the impact of intercostal neuralgia on quality of life and functional outcomes
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')
Measured: 1 and 3 months
Assess the impact of intercostal neuralgia on quality of life and functional outcomes
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)
Measured: 1 and 3 months
Assess the impact of intercostal neuralgia on medication use
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.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start19 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intercostal Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308587
- Sponsor's protocol ID
- SUN 6775
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 10866248Karmakar 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.
PubMed 12634549Bailey RC. Complications of tube thoracostomy in trauma. J Accid Emerg Med. 2000 Mar;17(2):111-4. doi: 10.1136/emj.17.2.111.
PubMed 10718232Fabricant 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.
PubMed 23592156Blyth 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.
PubMed 15327808
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Intercostal Neuralgia Incidence, Risk Factors, and Outcomes in Patients With Chest Tube Insertion After Traumatic Rib Fractures
- ClinicalTrials.gov ID
- NCT07308587
- Acronym / sponsor ID
- SUN 6775
- Conditions
- Intercostal Nerve Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest tube inserted | – | Procedure: Chest tube insertionPatients with acute traumatic rib fracture/chest injury requiring chest tube insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute traumatic rib fractures requiring chest tube insertion for management.
Key inclusion criteria (2 listed)
- Adults (≥18 years) with traumatic rib fractures requiring chest tube insertion
- Chest tube or pigtail insertion performed during their initial hospitalization for trauma
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest tube insertionInsertion of chest tube | Procedure or surgery | Chest tube inserted |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 10866248Bulger 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.
- Results publication: PubMed 12634549Karmakar 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.
- Results publication: PubMed 10718232Bailey RC. Complications of tube thoracostomy in trauma. J Accid Emerg Med. 2000 Mar;17(2):111-4. doi: 10.1136/emj.17.2.111.
- Results publication: PubMed 23592156Fabricant 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.
- Results publication: PubMed 15327808Blyth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intercostal Nerve Injury, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Howard Meng, MD (416-480-4864, howard.meng@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intercostal neuralgia (time frame: 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07308587, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.