Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Rib Fractures Clinical Trial

Official title:

Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330611
• Other study ID #: 64713
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Alexandra Myers, BA
• Phone: (650)498-3284
• Email: amyers19[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.

The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

Description:

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.

Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9

• Pain score equal to or greater than 5 with deep inspiration

• Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay

Exclusion Criteria:

• Radiographic evidence of metastasis to ribs

• Glasgow Coma Scale (GCS) score <13

• Patients undergoing SSRF (Surgical stabilization of rib fractures)

• Rib fractures located < 3cm from spinous process

• Coagulopathy (INR >1.5, Plt < 100)

• Other factors precluding cryoneurolysis at the attending's discretion

• If only ribs broken are 1,2 or 10,11,12

• Inability to be positioned for the procedure

• If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Device:
• Cryoneurolysis of Intercostal Nerves
Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190. The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures. This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures. Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Other:
• Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury. Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (27)

Byas-Smith MG, Gulati A. Ultrasound-guided intercostal nerve cryoablation. Anesth Analg. 2006 Oct;103(4):1033-5. doi: 10.1213/01.ane.0000237290.68166.c2. — View Citation

Chen Zhu R, de Roulet A, Ogami T, Khariton K. Rib fixation in geriatric trauma: Mortality benefits for the most vulnerable patients. J Trauma Acute Care Surg. 2020 Jul;89(1):103-110. doi: 10.1097/TA.0000000000002666. — View Citation

de Jong MB, Kokke MC, Hietbrink F, Leenen LP. Surgical Management of Rib Fractures: Strategies and Literature Review. Scand J Surg. 2014 Jun;103(2):120-125. doi: 10.1177/1457496914531928. Epub 2014 Apr 29. — View Citation

Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007. — View Citation

Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022. — View Citation

Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209. — View Citation

Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31. — View Citation

Harbaugh CM, Johnson KN, Kein CE, Jarboe MD, Hirschl RB, Geiger JD, Gadepalli SK. Comparing outcomes with thoracic epidural and intercostal nerve cryoablation after Nuss procedure. J Surg Res. 2018 Nov;231:217-223. doi: 10.1016/j.jss.2018.05.048. Epub 2018 Jun 21. — View Citation

Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. — View Citation

Keller BA, Kabagambe SK, Becker JC, Chen YJ, Goodman LF, Clark-Wronski JM, Furukawa K, Stark RA, Rahm AL, Hirose S, Raff GW. Intercostal nerve cryoablation versus thoracic epidural catheters for postoperative analgesia following pectus excavatum repair: Preliminary outcomes in twenty-six cryoablation patients. J Pediatr Surg. 2016 Dec;51(12):2033-2038. doi: 10.1016/j.jpedsurg.2016.09.034. Epub 2016 Sep 28. — View Citation

Koethe Y, Mannes AJ, Wood BJ. Image-guided nerve cryoablation for post-thoracotomy pain syndrome. Cardiovasc Intervent Radiol. 2014 Jun;37(3):843-6. doi: 10.1007/s00270-013-0718-8. Epub 2013 Aug 17. — View Citation

Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8. — View Citation

Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21. — View Citation

Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3. — View Citation

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5. — View Citation

Pieracci FM, Leasia K, Bauman Z, Eriksson EA, Lottenberg L, Majercik S, Powell L, Sarani B, Semon G, Thomas B, Zhao F, Dyke C, Doben AR. A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL). J Trauma Acute Care Surg. 2020 Feb;88(2):249-257. doi: 10.1097/TA.0000000000002559. — View Citation

Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available. — View Citation

Ryb GE, Dischinger PC, Burch CA, Kerns TJ, Kufera J, Andersen D. Frailty and injury causation. Ann Adv Automot Med. 2012;56:175-81. — View Citation

Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406. — View Citation

Shi HH, Esquivel M, Staudenmayer KL, Spain DA. Effects of mechanism of injury and patient age on outcomes in geriatric rib fracture patients. Trauma Surg Acute Care Open. 2017 Mar 16;2(1):e000074. doi: 10.1136/tsaco-2016-000074. eCollection 2017. — View Citation

Tignanelli CJ, Rix A, Napolitano LM, Hemmila MR, Ma S, Kummerfeld E. Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers. JAMA Netw Open. 2020 Mar 2;3(3):e201316. doi: 10.1001/jamanetworkopen.2020.1316. — View Citation

Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048. — View Citation

Vossler JD, Zhao FZ. Intercostal nerve cryoablation for control of traumatic rib fracture pain: A case report. Trauma Case Rep. 2019 Jul 31;23:100229. doi: 10.1016/j.tcr.2019.100229. eCollection 2019 Oct. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. — View Citation

Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573. — View Citation

Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017. — View Citation

Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Numeric Pain Score	Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.	12 months
Primary	Length of hospital stay	The length of hospital stay will be obtained from the patient's chart after discharge.	Up to 1 month
Primary	Daily Narcotic Equivalents	Morphine Milligram Equivalents (MME)	12 Months
Secondary	30-day mortality	Will be obtained from chart review after discharge	1 month
Secondary	Need for ICU admission	Will be obtained from chart review after discharge	1 month
Secondary	30-day rib-specific admission	Incidence of rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain)	1 month
Secondary	The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score	The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/clinical staff during follow up. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels.	30 days, 90 days, 365 days
Secondary	The Glasgow Outcome Scale Extended (GOS-E) Score	The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category: Death (D); Vegetative state (VS); Lower severe disability (SD -); Upper severe disability (SD +); Lower moderate disability ( MD -); Upper moderate disability ( MD +); Lower good recovery (GR -); Upper good recovery (GR +); The questionnaire will be administered to the patient by study/clinical staff during follow up.	30 days, 90 days, 365 days
Secondary	Short Form (SF-12) Health Survey Scale Score	The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff during follow up.; Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time).	30 days, 90 days, 365 days