Expired Study
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Denver, Colorado 80204


Purpose:

The investigators plan to compare the incidence of successful placement of epidural pain catheters versus paracostal catheters for the control of pain and prevention of pulmonary complications for adult trauma patients with blunt chest wall trauma resulting in multiple rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is being admitted to the Surgical ICU, and is encountered within 72 hours from the time of their injury, they will be eligible for the study. If they (or a proxy) choose to participate, consent will be obtained and they will randomly be assigned to receive either an epidural or paracostal catheter for pain control. The aim of the study is to determine if paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma patients. Secondarily the investigators will evaluate success and time of placement of the assigned intervention and follow the patient throughout their hospital course to compare the success of analgesia provided by each modality along with any complications and/or benefits of the two types of catheters.


Criteria:

Inclusion Criteria: - >/= 3 rib fractures on a single side - Admitted to the Surgical ICU - Recruited within 24 hours of admission Exclusion Criteria: - Patient allergy to local anesthetics - Patient refusal - Inability to consent for any reason - Prisoners - Age < 18 - Pregnant women (pregnancy screen performed as part of routine trauma admission labs) - Absolute contraindications for either thoracic epidural or paracostal pain catheter placement which include: 1. Localized rash or skin infection over the likely site of insertion (We never want to translocate infectious material from the skin to the epidural space or even into the soft tissue where paracostal catheters lay, although for these there is more flexibility in adjusting placement) 2. Spinal/vertebral instability/fracture including any significant vertebral body injury and 3 or more spinous process fractures near the level of desired epidural placement (transverse process fractures are not considered a contraindication) 3. History of extensive back surgery at the level of desired epidural placement 4. Severe aortic stenosis, mitral stenosis, or pulmonary hypertension 5. Inability to correct coagulopathy (to International Normalized Ratio>1.5) 6. Persistent hemodynamic instability (hypotension with Systolic Blood Pressure<90 that does not respond to initial fluid boluses and requires ongoing pressors beyond the 72 hour window for enrollment) 7. Inability to cooperate and participate in placement (if intubated and sedated, for example) or to lie in the correct position for placement (lateral decubitus for paracostal pain catheters, either sitting up or lateral decubitus for epidural placement) 8. Concern for elevated intracranial pressure (we imagine these patients will also be intubated)


Study is Available At:


Original ID:

14-1979


NCT ID:

NCT02295098


Secondary ID:


Study Acronym:


Brief Title:

Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures


Official Title:

Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Nina E Glass, MD
Principal Investigator
Denver Health Medical Center, Department of Surgery, University of Colorado, Denver

Study Dates

Start Date:August 19, 2015
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 6, 2018
First Received Date:November 9, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pain assessment immediately before and after catheter placement
Time Frame:within an hour before and after catheter placement
Safety Issues:False
Description:Pain scores are assessed by nursing on an hourly basis in the ICU
Outcome Type:Secondary Outcome
Measure:successful placement of randomized intervention (paracostal vs. epidural catheter)
Time Frame:Within 24 hours of recruitment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of analgesic effect as measured by daily pain scores
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Description:Daily pain scores are assessed by nursing hourly in the ICU and every shift after transfer to the floor. These are measured by the Critical-Care Pain Observation Tool (CPOT).
Outcome Type:Secondary Outcome
Measure:Comparison of improvements in pulmonary function
Time Frame:Duration of admission up to 30 days as long as the patient remains in the ICU
Safety Issues:False
Description:Respiratory therapist assessment of pulmonary function (including incentive spirometry maximum, forced vital capacity, peak expiratory flow, respiratory rate and supplemental oxygen requirement) every shift will be reviewed for evidence of respiratory emb
Outcome Type:Secondary Outcome
Measure:Comparison of improvements in maximum daily incentive spirometry
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Description:Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.
Outcome Type:Secondary Outcome
Measure:Comparison of improvements in forced vital capacity
Time Frame:Duration of admission up to 30 days as long as the patient remains in the ICU
Safety Issues:False
Description:Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.
Outcome Type:Secondary Outcome
Measure:Comparison of improvements in peak expiratory flow
Time Frame:Duration of admission up to 30 days as long as the patient remains in the ICU
Safety Issues:False
Description:Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.
Outcome Type:Secondary Outcome
Measure:Number of patients in each group with pulmonary complications
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Description:All patients will be assessed daily for other evidence of respiratory embarrassment including: hypoxemia, pneumonia, empyema, need for mechanical ventilation, or readmission due to pulmonary complaints.
Outcome Type:Secondary Outcome
Measure:ICU length of stay
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Hospital length of stay
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:30-day Mortality
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of daily requirement for narcotics and other additional pain medications.
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)
Time Frame:Duration of admission up to 30 days
Safety Issues:False
Description:We will assess any possible alterations in care related to interventions (e.g., failure to mobilize, anticoagulate, etc.).

Study Interventions

Intervention Type:Other
Name:Thoracic epidural catheter placement
Description:Thoracic epidurals work by delivering local anesthetics and narcotics to the epidural space, which then diffuse into the spinal nerve roots and block the transmission of pain from the chest wall to the spinal cord and brain.
Arm Name:Thoracic epidural catheter
Intervention Type:Other
Name:Paracostal catheter placement
Description:Paracostal catheters run along the outer surface of the chest wall and act by delivering local anesthetics to the intercostal nerves as traverse the lower border of the ribs.
Arm Name:Paracostal catheter

Study Arms

Study Arm Type:Active Comparator
Arm Name:Thoracic epidural catheter
Description:Thoracic epidurals work by delivering local anesthetics and narcotics to the epidural space, which then diffuse into the spinal nerve roots and block the transmission of pain from the chest wall to the spinal cord and brain.
Study Arm Type:Active Comparator
Arm Name:Paracostal catheter
Description:Paracostal catheters run along the outer surface of the chest wall and act by delivering local anesthetics to the intercostal nerves as traverse the lower border of the ribs.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Truitt MS, Murry J, Amos J, Lorenzo M, Mangram A, Dunn E, Moore EE. Continuous intercostal nerve blockade for rib fractures: ready for primetime? J Trauma. 2011 Dec;71(6):1548-52; discussion 1552. doi: 10.1097/TA.0b013e31823c96e0.
PMID:22182865
Reference Type:Results Reference
Citation:Mohta M, Verma P, Saxena AK, Sethi AK, Tyagi A, Girotra G. Prospective, randomized comparison of continuous thoracic epidural and thoracic paravertebral infusion in patients with unilateral multiple fractured ribs--a pilot study. J Trauma. 2009 Apr;66(4):1096-101. doi: 10.1097/TA.0b013e318166d76d.
PMID:19359920
Reference Type:Reference
Citation:Brasel KJ, Guse CE, Layde P, Weigelt JA. Rib fractures: relationship with pneumonia and mortality. Crit Care Med. 2006 Jun;34(6):1642-6.
PMID:16625122
Reference Type:Reference
Citation:Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7.
PMID:10866248
Reference Type:Reference
Citation:Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30.
PMID:15300210
Reference Type:Reference
Citation:Carrier FM, Turgeon AF, Nicole PC, Trépanier CA, Fergusson DA, Thauvette D, Lessard MR. Effect of epidural analgesia in patients with traumatic rib fractures: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2009 Mar;56(3):230-42. doi: 10.1007/s12630-009-9052-7. Epub 2009 Feb 11. Review.
PMID:19247744
Reference Type:Reference
Citation:Dahlgren N, Törnebrandt K. Neurological complications after anaesthesia. A follow-up of 18,000 spinal and epidural anaesthetics performed over three years. Acta Anaesthesiol Scand. 1995 Oct;39(7):872-80.
PMID:8848884
Reference Type:Reference
Citation:Gebhardt R, Mehran RJ, Soliz J, Cata JP, Smallwood AK, Feeley TW. Epidural versus ON-Q local anesthetic-infiltrating catheter for post-thoracotomy pain control. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):423-6. doi: 10.1053/j.jvca.2013.02.017.
PMID:23672860
Reference Type:Reference
Citation:Grider JS, Mullet TW, Saha SP, Harned ME, Sloan PA. A randomized, double-blind trial comparing continuous thoracic epidural bupivacaine with and without opioid in contrast to a continuous paravertebral infusion of bupivacaine for post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):83-9. doi: 10.1053/j.jvca.2011.09.003. Epub 2011 Nov 17.
PMID:22100213
Reference Type:Reference
Citation:Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f. Review.
PMID:21716105
Reference Type:Reference
Citation:Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55.
PMID:12691929
Reference Type:Reference
Citation:Moon MR, Luchette FA, Gibson SW, Crews J, Sudarshan G, Hurst JM, Davis K Jr, Johannigman JA, Frame SB, Fischer JE. Prospective, randomized comparison of epidural versus parenteral opioid analgesia in thoracic trauma. Ann Surg. 1999 May;229(5):684-91; discussion 691-2.
PMID:10235527
Reference Type:Reference
Citation:Sirmali M, Türüt H, Topçu S, Gülhan E, Yazici U, Kaya S, Taştepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8.
PMID:12853057
Reference Type:Reference
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.
PMID:20567973
Reference Type:Reference
Citation:Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67.
PMID:16385313

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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