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Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Primary Purpose

3 or More Rib Fractures

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ON-Q® Pain Relief System

Thoracic epidural catheter

About this trial

This is an interventional supportive care trial for 3 or More Rib Fractures focused on measuring ON-Q, epidural, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age ≥ 18 years;
Three or more rib fractures;
Pain
1. Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
2. Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
Patient has capacity to provide informed consent, as determined by:
1. Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
2. GCS 15;
3. Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.

Exclusion criteria:

Lack capacity to provide informed consent;
Intubation at time of enrollment;
Contraindications to procedure (e.g. known allergy to local anesthetics).
Presence of infection at site of catheter placement;
Current use of anticoagulant medication;
Known allergy to silver;
Inability to obtain informed consent;
Body weight > 300 lbs;
Pregnancy;
Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).

All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paravertebral catheter (ON-Q® Pain Relief System)

Thoracic epidural catheter

Arm Description

Outcomes

Primary Outcome Measures

Hospital length of stay/time to achieve discharge criteria

The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria: Visual Analog Score (VAS) for pain below 4 (of a maximum 10); Ability to perform incentive spirometry with sustained maximal inspiration for three seconds; Hemodynamic stability (heart rate <100 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure >90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air; Absence of neurological deficits; and Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.

Secondary Outcome Measures

Pain score reduction

Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.

Full Information

NCT ID

NCT01401712

First Posted

July 21, 2011

Last Updated

October 28, 2013

Sponsor

Massachusetts General Hospital

Collaborators

I-Flow

1. Study Identification

Unique Protocol Identification Number

NCT01401712

Brief Title

Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Official Title

Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

I-Flow

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications. An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

3 or More Rib Fractures

Keywords

ON-Q, epidural, analgesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paravertebral catheter (ON-Q® Pain Relief System)

Arm Type

Experimental

Arm Title

Thoracic epidural catheter

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

ON-Q® Pain Relief System

Intervention Description

Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr.

Intervention Type

Procedure

Intervention Name(s)

Thoracic epidural catheter

Intervention Description

Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle.

Primary Outcome Measure Information:

Title

Hospital length of stay/time to achieve discharge criteria

Description

Time Frame

Patient will be followed for the duration of hospital stay, 1 week

Secondary Outcome Measure Information:

Title

Pain score reduction

Description

Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.

Time Frame

Patient will be followed for duration of hospital stay and through daily phone calls upon discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age ≥ 18 years; Three or more rib fractures; Pain Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours; Patient has capacity to provide informed consent, as determined by: Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD; GCS 15; Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD. Exclusion criteria: Lack capacity to provide informed consent; Intubation at time of enrollment; Contraindications to procedure (e.g. known allergy to local anesthetics). Presence of infection at site of catheter placement; Current use of anticoagulant medication; Known allergy to silver; Inability to obtain informed consent; Body weight > 300 lbs; Pregnancy; Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease). All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katharine M Koury, BA

Phone

617-643-7095

kkoury@partners.org

First Name & Middle Initial & Last Name or Official Title & Degree

Leily Naraghi, MD

Phone

617-480-1668

lnaraghi@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George C Velmahos, Md, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katharine M Koury, BA

Phone

617-643-7095

kkoury@partners.org

First Name & Middle Initial & Last Name & Degree

George C Velmahos, MD, PhD

First Name & Middle Initial & Last Name & Degree

Padma Gulur, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20567973

Citation

Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.

Results Reference

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Optimal Method of Pain Management in Patients With Multiple Rib Fractures

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