Clinical trial NCT02604589: Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
Official title: Prime "Rib" Time: Randomized Control Trial Evaluating the Use of Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rib Fractures
Keywords: Catheters, Indwelling
Infusion Pumps
Anesthesia, Local
Analgesia, Patient-Controlled
Bupivacaine
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2015-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 require less narcotic pain medication, achieve discharge criteria earlier and have a shorter hospital length of stay in comparison to patients treated with PCA alone.

Eligibility criteria: Inclusion Criteria:

* Admission to trauma service at Beaumont Hospital, Royal Oak, Michigan
* Two or more rib fractures in an anatomic pattern feasible for nerve blockade (unilateral or bilateral)
* 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 (eg., traumatic brain injury)
* 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

Primary outcomes:
measure: Narcotic Use
timeFrame: 3 days or hospital length of stay, if less than 3 days
Secondary outcomes:
measure: Time to Improvement in Pulmonary Function
timeFrame: 3 days or hospital length of stay, if less than 3 days
measure: Time to Improvement in Pain Intensity
timeFrame: 3 days or hospital length of stay, if less than 3 days
measure: Morbidity
timeFrame: 3 days or hospital length of stay, whichever is longer
measure: Mortality
timeFrame: 30 days
measure: Hospital Length of Stay
timeFrame: from randomization to discharge, usually within the range of 5-15 days
measure: Surgical Intensive Care Unit (SICU) Length of Stay
timeFrame: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Hospital, Royal Oak MI
name: Anthony Iacco, MD
role: PRINCIPAL_INVESTIGATOR
References: