Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures

NCT02604589 | Terminated Results DMC

• 1 other identifier: 2015-233
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Keywords

Catheters, Indwelling; Infusion Pumps; Anesthesia, Local; Analgesia, Patient-Controlled; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Time to Improvement in Pulmonary Function

  3 days or hospital length of stay, if less than 3 days

• Time to Improvement in Pain Intensity

  3 days or hospital length of stay, if less than 3 days

• Morbidity

  3 days or hospital length of stay, whichever is longer

• Mortality

  30 days

• Hospital Length of Stay

  from randomization to discharge, usually within the range of 5-15 days

Study Arms (3)

PCA only

PLACEBO COMPARATOR

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.

Drug: hydromorphone hydrochloride

Bupivicaine 0.25% (LOW DOSE)

EXPERIMENTAL

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.

Drug: hydromorphone hydrochloride; Procedure: Infusion catheter placement; Drug: bupivicaine 0.25%

Bupivicaine 0.5% (HIGH DOSE)

EXPERIMENTAL

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.

Drug: hydromorphone hydrochloride; Procedure: Infusion catheter placement; Drug: bupivicaine 0.5%

Interventions

hydromorphone hydrochloride DRUG

Patient-controlled narcotic analgesia pump

Also known as: Dilaudid

Bupivicaine 0.25% (LOW DOSE); Bupivicaine 0.5% (HIGH DOSE); PCA only

Infusion catheter placement PROCEDURE

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

Also known as: OnQ pump placement

Bupivicaine 0.25% (LOW DOSE); Bupivicaine 0.5% (HIGH DOSE)

bupivicaine 0.25% DRUG

Low Dose analgesia

Also known as: Marciane

Bupivicaine 0.25% (LOW DOSE)

bupivicaine 0.5% DRUG

High dose analgesia

Also known as: Marcaine

Bupivicaine 0.5% (HIGH DOSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthony Iacco: lead
• Corewell Health East: collaborator

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Rib Fractures; Agnosia

Interventions

Hydromorphone; Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Study terminated early due to lack of enrollment.

Results Point of Contact

• Title: Rose Callahan
• Organization: William Beaumont Hospital

rose.callahan@beaumont.org

248 551-5147

Study Officials

• Anthony Iacco, MD

  Beaumont Hospital, Royal Oak MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 13, 2015
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)