Optimal Method of Pain Management in Patients With Multiple Rib Fractures
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2012 |
| End Date: | October 2014 |
| Contact: | Katharine M Koury, BA |
| Email: | kkoury@partners.org |
| Phone: | 617-643-7095 |
Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
