Optimal Method of Pain Management in Patients With Multiple Rib Fractures
Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 29, 2013
October 1, 2013
1.5 years
July 21, 2011
October 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
Patient will be followed for the duration of hospital stay, 1 week
Secondary Outcomes (1)
Pain score reduction
Patient will be followed for duration of hospital stay and through daily phone calls upon discharge
Study Arms (2)
Paravertebral catheter (ON-Q® Pain Relief System)
EXPERIMENTALThoracic epidural catheter
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- I-Flowcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 20567973BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George C Velmahos, Md, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Chief, Trauma, Emergency Surgery, Surgical Critical Care
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 25, 2011
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
October 1, 2014
Last Updated
October 29, 2013
Record last verified: 2013-10