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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295098
• Other study ID #: 14-1979
• Status: Completed
• Phase: N/A
• Start date: August 19, 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures
• Wounds and Injuries

Intervention

Other:
• Thoracic epidural catheter placement
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.
• Paracostal catheter placement
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.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (15)

Brasel KJ, Guse CE, Layde P, Weigelt JA. Rib fractures: relationship with pneumonia and mortality. Crit Care Med. 2006 Jun;34(6):1642-6. — View 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. — View Citation

Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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): — View 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. — View 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. — View Citation

Sirmali M, Türüt H, Topçu S, Gülhan 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	successful placement of randomized intervention (paracostal vs. epidural catheter)		Within 24 hours of recruitment
Secondary	Comparison of analgesic effect as measured by daily pain scores	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).	Duration of admission up to 30 days
Secondary	Comparison of improvements in pulmonary function	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 embarrassment.	Duration of admission up to 30 days as long as the patient remains in the ICU
Secondary	Comparison of improvements in maximum daily incentive spirometry	Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.	Duration of admission up to 30 days
Secondary	Comparison of improvements in forced vital capacity	Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.	Duration of admission up to 30 days as long as the patient remains in the ICU
Secondary	Comparison of improvements in peak expiratory flow	Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.	Duration of admission up to 30 days as long as the patient remains in the ICU
Secondary	Number of patients in each group with pulmonary complications	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.	Duration of admission up to 30 days
Secondary	ICU length of stay		Duration of admission up to 30 days
Secondary	Hospital length of stay		Duration of admission up to 30 days
Secondary	30-day Mortality		Duration of admission up to 30 days
Secondary	Comparison of daily requirement for narcotics and other additional pain medications.		Duration of admission up to 30 days
Secondary	Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)	We will assess any possible alterations in care related to interventions (e.g., failure to mobilize, anticoagulate, etc.).	Duration of admission up to 30 days