Clinical trial NCT01401712: Optimal Method of Pain Management in Patients With Multiple Rib Fractures
Official title: Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 3 or More Rib Fractures
Keywords: ON-Q
epidural
analgesia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: I-Flow
First posted: 2011-07-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria:

1. Age ≥ 18 years;
2. Three or more rib fractures;
3. Pain

   1. Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
   2. Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
4. Patient has capacity to provide informed consent, as determined by:

   1. Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
   2. GCS 15;
   3. Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.

Exclusion criteria:

1. Lack capacity to provide informed consent;
2. Intubation at time of enrollment;
3. Contraindications to procedure (e.g. known allergy to local anesthetics).
4. Presence of infection at site of catheter placement;
5. Current use of anticoagulant medication;
6. Known allergy to silver;
7. Inability to obtain informed consent;
8. Body weight \> 300 lbs;
9. Pregnancy;
10. Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).

All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.

Primary outcomes:
measure: Hospital length of stay/time to achieve discharge criteria
timeFrame: Patient will be followed for the duration of hospital stay, 1 week
Secondary outcomes:
measure: Pain score reduction
timeFrame: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: George C Velmahos, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.