Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures



Status:Not yet recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2016
End Date:March 2018
Contact:Shruti Sevak, MD
Email:Shruti.Sevak@beaumont.edu
Phone:248 470-6301

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Prime "Rib" Time: Randomized Control Trial Evaluating the Use of Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures

Rib fractures are common injuries in accident patients and can be associated with
significant pain during recovery. If poorly controlled, pain from splinting due to rib
fractures can result in difficulty in breathing leading to incomplete expansion of lung, and
even the need to put a patient on a ventilator to help them breathe. Therefore, pain control
is critical in managing patients with rib fractures. To date, many studies have shown the
effectiveness of continuous intercostal nerve blockade (a slow release of pain medications
at the site of injury that prevents the transmission of pain signals). This approach has
never been studied in a randomized fashion in rib fracture patients, and has never been
compared to patient-controlled narcotic pain medication, commonly used at many hospitals.
The purpose of this study is to evaluate the effectiveness of the placement of an
elastomeric infusion pump (a small, external, wearable balloon used to deliver medication
over time) attached to a continuous infusion catheter or "soaker" catheter (a tube which
releases the pain medication through tiny holes in it, right at the site of injury) to
deliver local anesthetic medication to reduce pain caused by two or more rib fractures.

Treatment of rib fractures using an elastomeric infusion pump (a small, external, wearable
balloon used to deliver medication over time) containing pain medication and a continuous
infusion catheter or "soaker" catheter (a tube which releases the pain medication through
tiny holes in it, right at the site of injury)placed in the extrathoracic paraspinous space
(a site in the back that is near the broken ribs) to create a continuous intercostal nerve
block is relatively novel. Truitt and colleagues have published two studies evaluating the
effectiveness of this approach. A pilot study on 30 patients was published in 2010 showing
that placement of these catheters was a safe, viable and effective procedure, and resulted
in decreased pain scores in rib fracture patients. A second study included 102 patients
studied prospectively (from the time of admission to the hospital) comparing epidural
anesthesia (an injection of anesthetic into the spine)with local catheter delivery in a
non-randomized fashion in 2011. This approach is beginning to be more widely used, but has
never been studied in a randomized fashion, and has never been compared to
patient-controlled analgesia (PCA, delivery of a pain medication by the push of a button),
commonly used at many hospitals.

We hypothesize that accident patients with two or more rib fractures who receive pain
control through the continuous infusion system will achieve improved pain control in a
dose-dependent fashion, improved lung function, and therefore, will achieve discharge
criteria earlier and have a shorter hospital length of stay in comparison to patients
treated with PCA alone.

Inclusion Criteria:

- Admission to trauma service at Beaumont Hospital, Royal Oak, Michigan

- Two or more unilateral rib fractures in an anatomic pattern feasible for nerve
blockade

- Age greater than or equal to 18 years

- Ability to comprehend and endorse an informed consent

Exclusion Criteria:

- Patients who are pregnant or breastfeeding

- Patients intubated before placement of continuous infusion catheter

- Any significant concomitant injuries potentially confounding for evaluation of the
effectiveness of analgesia (traumatic brain injury, pelvic fracture, and long bone
fracture)

- History of an allergic reaction to local anesthetic

- Use of other regional anesthetics before evaluation (epidural or paravertebral nerve
blockade)

- International Normalized Ratio (INR) > 2.0

- Inability to obtain informed consent
We found this trial at
1
site
Royal Oak, Michigan 48314
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mi
from
Royal Oak, MI
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