Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Not Applicable

• Conditions: 3 or More Rib Fractures
• Interventions: Procedure: ON-Q® Pain Relief System; Procedure: Thoracic epidural catheter

• Registration Number: NCT01401712
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.

An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Study Start: 2012-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29
• Primary Completion: 2014-04
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral catheter (ON-Q® Pain Relief System)	ON-Q® Pain Relief System	-
Thoracic epidural catheter	Thoracic epidural catheter	-

Primary Outcome Measures

Name	Time	Method
Hospital length of stay/time to achieve discharge criteria	Patient will be followed for the duration of hospital stay, 1 week	The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria: 1. Visual Analog Score (VAS) for pain below 4 (of a maximum 10); 2. Ability to perform incentive spirometry with sustained maximal inspiration for three seconds; 3. Hemodynamic stability (heart rate \<100 beats/min, respiratory rate \<20 breaths/min, and systolic blood pressure \>90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air; 4. Absence of neurological deficits; and; 5. Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.

Secondary Outcome Measures

Name	Time	Method
Pain score reduction	Patient will be followed for duration of hospital stay and through daily phone calls upon discharge	Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States