NCT07308587

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

September 5, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 5, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 and 3 months

Secondary Outcomes (3)

  • Assess the impact of intercostal neuralgia on quality of life and functional outcomes

    1 and 3 months

  • Assess the impact of intercostal neuralgia on quality of life and functional outcomes

    1 and 3 months

  • Assess the impact of intercostal neuralgia on medication use

    1 and 3 months

Study Arms (1)

Chest tube inserted

Patients with acute traumatic rib fracture/chest injury requiring chest tube insertion

Procedure: Chest tube insertion

Interventions

Insertion of chest tube

Chest tube inserted

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute traumatic rib fractures requiring chest tube insertion for management.

You may qualify if:

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

You may not qualify if:

  • Patients with traumatic brain injury
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2025

First Posted

December 29, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share