Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures

NCT ID: NCT02604589

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Rib Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PCA only

Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.

Group Type: PLACEBO_COMPARATOR

hydromorphone hydrochloride

Intervention Type: DRUG

Patient-controlled narcotic analgesia pump

Bupivicaine 0.25% (LOW DOSE)

Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.

Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.

Group Type: EXPERIMENTAL

hydromorphone hydrochloride

Intervention Type: DRUG

Patient-controlled narcotic analgesia pump

Infusion catheter placement

Intervention Type: PROCEDURE

Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space

bupivicaine 0.25%

Intervention Type: DRUG

Low Dose analgesia

Bupivicaine 0.5% (HIGH DOSE)

Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.

Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.

Group Type: EXPERIMENTAL

hydromorphone hydrochloride

Intervention Type: DRUG

Patient-controlled narcotic analgesia pump

Infusion catheter placement

Intervention Type: PROCEDURE

Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space

bupivicaine 0.5%

Intervention Type: DRUG

High dose analgesia

Interventions

hydromorphone hydrochloride

Patient-controlled narcotic analgesia pump

Intervention Type: DRUG

Infusion catheter placement

Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space

Intervention Type: PROCEDURE

bupivicaine 0.25%

Low Dose analgesia

Intervention Type: DRUG

bupivicaine 0.5%

High dose analgesia

Intervention Type: DRUG

Other Intervention Names

Dilaudid; OnQ pump placement; Marciane; Marcaine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: collaborator

Anthony Iacco

OTHER

Sponsor Role: lead

Responsible Party

Anthony Iacco

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Iacco, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital, Royal Oak MI

Locations

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2015-233

Identifier Type: -

Identifier Source: org_study_id