Recruiting

Pain Management

Sponsor:

Massachusetts General Hospital

Code:

NCT01401712

Conditions

3 or More Rib Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ON-Q® Pain Relief System

Thoracic epidural catheter

Study Details

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.

Conditions

3 or More Rib Fractures

Study ID

NCT01401712

Start date

Oct, 2012

Status verified date

Oct, 2013

Completion date

Oct, 2014

Anticipated

Primary completion date

Apr, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Paravertebral catheter (ON-Q® Pain Relief System)

active comparator: Thoracic epidural catheter

Interventions

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.

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.

Primary outcome measure

  • Hospital length of stay/time to achieve discharge criteria [ Time Frame: Patient will be followed for the duration of hospital stay, 1 week ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

George C Velmahos, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 29, 2013

Last verified

Oct, 2013

Keywords

  • ON-Q
  • epidural
  • analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2013-10-29.