Optimal Method of Pain Management in Patients With Multiple Rib Fractures

This study is currently recruiting participants.
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
George Velmahos, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01401712
First received: July 21, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
3 or More Rib Fractures
Procedure: ON-Q® Pain Relief System
Procedure: Thoracic epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hospital length of stay/time to achieve discharge criteria [ Time Frame: Patient will be followed for the duration of hospital stay, 1 week ] [ Designated as safety issue: No ]

    The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria:

    1. Visual Analog Score (VAS) for pain below 4 (of a maximum 10);
    2. Ability to perform incentive spirometry with sustained maximal inspiration for three seconds;
    3. 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;
    4. Absence of neurological deficits; and
    5. 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 [ Time Frame: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 96
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paravertebral catheter (ON-Q® Pain Relief System) Procedure: ON-Q® Pain Relief System
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.
Active Comparator: Thoracic epidural catheter Procedure: Thoracic epidural catheter
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age ≥ 18 years;
  2. Three or more rib fractures;
  3. 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;
  4. 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:

  1. Lack capacity to provide informed consent;
  2. Intubation at time of enrollment;
  3. Contraindications to procedure (e.g. known allergy to local anesthetics).
  4. Presence of infection at site of catheter placement;
  5. Current use of anticoagulant medication;
  6. Known allergy to silver;
  7. Inability to obtain informed consent;
  8. Body weight > 300 lbs;
  9. Pregnancy;
  10. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401712

Contacts
Contact: Katharine M Koury, BA 617-643-7095 kkoury@partners.org
Contact: Leily Naraghi, MD 617-480-1668 lnaraghi@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katharine M Koury, BA    617-643-7095    kkoury@partners.org   
Principal Investigator: George C Velmahos, MD, PhD         
Sub-Investigator: Padma Gulur, MD         
Sponsors and Collaborators
Massachusetts General Hospital
I-Flow
Investigators
Principal Investigator: George C Velmahos, Md, PhD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: George Velmahos, Division Chief, Trauma, Emergency Surgery, Surgical Critical Care, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01401712     History of Changes
Other Study ID Numbers: 2011P001678
Study First Received: July 21, 2011
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ON-Q
epidural
analgesia

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries

ClinicalTrials.gov processed this record on April 21, 2014