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

NCT02295098 | Completed

• 1 other identifier: 14-1979
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rib Fractures; Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Pain assessment immediately before and after catheter placement

  Pain scores are assessed by nursing on an hourly basis in the ICU

  within an hour before and after catheter placement

Secondary Outcomes (12)

• successful placement of randomized intervention (paracostal vs. epidural catheter)

  Within 24 hours of recruitment

• Comparison of analgesic effect as measured by daily pain scores

  Duration of admission up to 30 days

• Comparison of improvements in pulmonary function

  Duration of admission up to 30 days as long as the patient remains in the ICU

• Comparison of improvements in maximum daily incentive spirometry

  Duration of admission up to 30 days

• Comparison of improvements in forced vital capacity

  Duration of admission up to 30 days as long as the patient remains in the ICU

Study Arms (2)

Thoracic epidural catheter

ACTIVE COMPARATOR

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.

Other: Thoracic epidural catheter placement

Paracostal catheter

ACTIVE COMPARATOR

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.

Other: Paracostal catheter placement

Interventions

Thoracic epidural catheter placement OTHER

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.

Thoracic epidural catheter

Paracostal catheter placement OTHER

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.

Paracostal catheter

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 3 rib fractures on a single side
• Admitted to the Surgical ICU
• Recruited within 24 hours of admission

You may not qualify if:

• 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:
• 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)
• 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)
• History of extensive back surgery at the level of desired epidural placement
• Severe aortic stenosis, mitral stenosis, or pulmonary hypertension
• Inability to correct coagulopathy (to International Normalized Ratio\>1.5)
• 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)
• 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)
• Concern for elevated intracranial pressure (we imagine these patients will also be intubated)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (15)

• 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. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.

  PMID: 16385313 BACKGROUND

• 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 BACKGROUND

• Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.

  PMID: 12853057 BACKGROUND

• 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. doi: 10.1097/00000658-199905000-00011.

  PMID: 10235527 BACKGROUND

• 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. doi: 10.1016/S1072-7515(02)01894-X.

  PMID: 12691929 BACKGROUND

• 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.

  PMID: 21716105 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dahlgren N, Tornebrandt 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. doi: 10.1111/j.1399-6576.1995.tb04190.x.

  PMID: 8848884 BACKGROUND

• Carrier FM, Turgeon AF, Nicole PC, Trepanier 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.

  PMID: 19247744 BACKGROUND

• Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.

  PMID: 15300210 BACKGROUND

• Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.

  PMID: 10866248 BACKGROUND

• Brasel KJ, Guse CE, Layde P, Weigelt JA. Rib fractures: relationship with pneumonia and mortality. Crit Care Med. 2006 Jun;34(6):1642-6. doi: 10.1097/01.CCM.0000217926.40975.4B.

  PMID: 16625122 BACKGROUND

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Rib Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Thoracic Injuries

Study Officials

• Nina E Glass, MD

  Denver Health Medical Center, Department of Surgery, University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2014
• First Posted: November 20, 2014
• Study Start: August 19, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

US (1)