Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02604589
• Other study ID #: 2015-233
• Status: Active, not recruiting
• Phase: N/A
• First received: November 2, 2015
• Last updated: November 2, 2016
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: November 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Drug:
• hydromorphone hydrochloride
Patient-controlled narcotic analgesia pump

Procedure:
• Infusion catheter placement
Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space

Drug:
• bupivicaine 0.25%
Low Dose analgesia
• bupivicaine 0.5%
High dose analgesia

Locations

Country	Name	City	State
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Anthony Iacco	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Use	Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.	3 days or hospital length of stay, if less than 3 days	No
Secondary	Change in pulmonary function	Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).	3 days or hospital length of stay, if less than 3 days	No
Secondary	Change in pain intensity	Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.	3 days or hospital length of stay, if less than 3 days	No
Secondary	Morbidity	Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.	3 days or hospital length of stay, whichever is longer	Yes
Secondary	Mortality	All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.	30 days	Yes
Secondary	Hospital length of stay	Integer days of inpatient admission in the hospital stay that included randomization.	from randomization to discharge, an average of 5 days	No
Secondary	Surgical Intensive Care Unit length of stay	Integer days of admission to the surgical intensive care unit.	from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit, an average of 3 days	No

External Links

•   Beaumont Health System