Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures

Rib Fractures Clinical Trial

— SUETHE-Ribs  

Official title:

Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05069961
• Other study ID #: 11414
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

Description:

2.1 Primary Objective - Compare efficacy of ESPB to TEA for MRF analgesia. 2.2 Secondary Objective - Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA. 2.3 Tertiary/Exploratory/Correlative Objectives - Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement. - Compare complications that occur in patients who receive ESPB versus TEA. - Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB. - Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA. - Differences in length of stay (LOS) for TEA versus ESPB. - Differences in risk of delirium between TEA and ESPB. - Differences in oxygen and ventilatory support between TEA and ESPB. - Patient satisfaction of pain management.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Radiological evidence of 3 or more rib fractures
• Within 48 hours of admission to hospital with rib fractures
• Can actively participate by answering questions during TEA or ESPB placement
• Moderate-severe (4-10 out of 10) pain at the time of enrollment

Exclusion Criteria:

• Greater than 48 hrs since admission to the hospital with rib fractures
• Patient refusal
• Prisoner
• Infection at the site of TEA or ESPB insertion
• Allergy to local anesthetics
• Depth from skin to catheter placement target 6 or more centimeters
• Greater than 7 consecutive ribs involved on each side
• Other regional or epidural block already received
• Unable to follow commands/altered mental status
• Dementia
• Sepsis (temperature > 38 degrees Celsius & positive blood cultures)
• Elevated intracranial pressure (ICP > 12 mm Hg)
• Coagulopathy (INR > 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on)
• Preexisting central nervous system disorders, such as multiple sclerosis
• Thrombocytopenia (Platelets <70,000)
• Spine fracture or previous back surgery
• Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
• Aortic transection
• Hemodynamic instability (patients with MAPs <60 and/or patients requiring pressor support)
• Tattoo at sight of catheter placement

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• ESPB
Ropivacaine is injected near the nerves in the back
• TEA
Bupivacaine is injected into the space around the spinal cord.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

References & Publications (42)

Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10. — View Citation

Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17. — View Citation

Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296. — View Citation

Bergeron E, Lavoie A, Clas D, Moore L, Ratte S, Tetreault S, Lemaire J, Martin M. Elderly trauma patients with rib fractures are at greater risk of death and pneumonia. J Trauma. 2003 Mar;54(3):478-85. doi: 10.1097/01.TA.0000037095.83469.4C. — View Citation

Bomberg H, Bayer I, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Prolonged Catheter Use and Infection in Regional Anesthesia: A Retrospective Registry Analysis. Anesthesiology. 2018 Apr;128(4):764-773. doi: 10.1097/ALN.0000000000002105. — 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. doi: 10.1016/j.surg.2004.05.019. — View Citation

Cao J, Gao X, Zhang X, Li J, Zhang J. Feasibility of laryngeal mask anesthesia combined with nerve block in adult patients undergoing internal fixation of rib fractures: a prospective observational study. BMC Anesthesiol. 2020 Jul 15;20(1):170. doi: 10.1186/s12871-020-01082-y. — View Citation

Cicala RS, Voeller GR, Fox T, Fabian TC, Kudsk K, Mangiante EC. Epidural analgesia in thoracic trauma: effects of lumbar morphine and thoracic bupivacaine on pulmonary function. Crit Care Med. 1990 Feb;18(2):229-31. — View Citation

De Buck F, Devroe S, Missant C, Van de Velde M. Regional anesthesia outside the operating room: indications and techniques. Curr Opin Anaesthesiol. 2012 Aug;25(4):501-7. doi: 10.1097/ACO.0b013e3283556f58. — View Citation

El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available. — View Citation

Epidural Anesthesia and Analgesia [https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/abdomen/epidural-anesthesia-analgesia/]

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

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Gabram SG, Schwartz RJ, Jacobs LM, Lawrence D, Murphy MA, Morrow JS, Hopkins JS, Knauft RF. Clinical management of blunt trauma patients with unilateral rib fractures: a randomized trial. World J Surg. 1995 May-Jun;19(3):388-93. doi: 10.1007/BF00299166. — 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

Geerts WH, Jay RM, Code KI, Chen E, Szalai JP, Saibil EA, Hamilton PA. A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. N Engl J Med. 1996 Sep 5;335(10):701-7. doi: 10.1056/NEJM199609053351003. — View Citation

Govindarajan R, Bakalova T, Michael R, Abadir AR. Epidural buprenorphine in management of pain in multiple rib fractures. Acta Anaesthesiol Scand. 2002 Jul;46(6):660-5. doi: 10.1034/j.1399-6576.2002.460605.x. — View Citation

Gursoy C, Kuscu Y, Demirbilek SG. Pain Management for Traumatic Rib Fractures with ESP Block in ICU. J Coll Physicians Surg Pak. 2020 Mar;30(3):318-320. doi: 10.29271/jcpsp.2020.03.318. — 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. — View Citation

Jain K, Jaiswal V, Puri A. Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. Indian J Anaesth. 2018 Oct;62(10):809-813. doi: 10.4103/ija.IJA_263_18. — View Citation

Jensen CD, Stark JT, Jacobson LL, Powers JM, Joseph MF, Kinsella-Shaw JM, Denegar CR. Improved Outcomes Associated with the Liberal Use of Thoracic Epidural Analgesia in Patients with Rib Fractures. Pain Med. 2017 Sep 1;18(9):1787-1794. doi: 10.1093/pm/pnw199. — View Citation

Karmakar MK, Ho AM. Acute pain management of patients with multiple fractured ribs. J Trauma. 2003 Mar;54(3):615-25. doi: 10.1097/01.TA.0000053197.40145.62. — View Citation

Kunhabdulla NP, Agarwal A, Gaur A, Gautam SK, Gupta R, Agarwal A. Serratus anterior plane block for multiple rib fractures. Pain Physician. 2014 Sep-Oct;17(5):E651-3. No abstract available. — View Citation

Liu R, Clark L, Bautista A. Unilateral Bilevel Erector Spinae Plane Catheters for Flail Chest: A Case Report. A A Pract. 2020 May;14(7):e01211. doi: 10.1213/XAA.0000000000001211. — View Citation

Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x. — View Citation

Mackersie RC, Karagianes TG, Hoyt DB, Davis JW. Prospective evaluation of epidural and intravenous administration of fentanyl for pain control and restoration of ventilatory function following multiple rib fractures. J Trauma. 1991 Apr;31(4):443-9; discussion 449-51. — View Citation

Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113. — View Citation

Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61. — 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):1096-101. doi: 10.1097/TA.0b013e318166d76d. — 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. doi: 10.1097/00000658-199905000-00011. — View Citation

Nandhakumar A, Nair A, Bharath VK, Kalingarayar S, Ramaswamy BP, Dhatchinamoorthi D. Erector spinae plane block may aid weaning from mechanical ventilation in patients with multiple rib fractures: Case report of two cases. Indian J Anaesth. 2018 Feb;62(2):139-141. doi: 10.4103/ija.IJA_599_17. — View Citation

Osinowo OA, Zahrani M, Softah A. Effect of intercostal nerve block with 0.5% bupivacaine on peak expiratory flow rate and arterial oxygen saturation in rib fractures. J Trauma. 2004 Feb;56(2):345-7. doi: 10.1097/01.TA.0000046257.70194.2D. — View Citation

Richardson J, Sabanathan S, Mearns AJ, Shah RD, Goulden C. A prospective, randomized comparison of interpleural and paravertebral analgesia in thoracic surgery. Br J Anaesth. 1995 Oct;75(4):405-8. doi: 10.1093/bja/75.4.405. — View Citation

Rogers FB, Cipolle MD, Velmahos G, Rozycki G, Luchette FA. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma. 2002 Jul;53(1):142-64. doi: 10.1097/00005373-200207000-00032. No abstract available. — View Citation

Shanti CM, Carlin AM, Tyburski JG. Incidence of pneumothorax from intercostal nerve block for analgesia in rib fractures. J Trauma. 2001 Sep;51(3):536-9. doi: 10.1097/00005373-200109000-00019. — View Citation

Shibata Y, Kampitak W, Tansatit T. The Novel Costotransverse Foramen Block Technique: Distribution Characteristics of Injectate Compared with Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E305-E314. — View Citation

Shorr RM, Crittenden M, Indeck M, Hartunian SL, Rodriguez A. Blunt thoracic trauma. Analysis of 515 patients. Ann Surg. 1987 Aug;206(2):200-5. doi: 10.1097/00000658-198708000-00013. — View Citation

Short K, Scheeres D, Mlakar J, Dean R. Evaluation of intrapleural analgesia in the management of blunt traumatic chest wall pain: a clinical trial. Am Surg. 1996 Jun;62(6):488-93. — 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. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available. — View Citation

Xu J, Murphy SL, Kochanek KD, Arias E: Mortality in the United States, 2018. In. Edited by Services USDoHaH. Online: National Center for Health Statistics; 2020.

Yayik AM, Ahiskalioglu A, Celik EC, Ay A, Ozenoglu A. [Continuous erector spinae plane block for postoperative analgesia of multiple rib fracture surgery: case report]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):91-94. doi: 10.1016/j.bjan.2018.08.001. Epub 2018 Nov 2. — 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 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incentive spirometry	Maximum incentive spirometry volume (in mL) will be gathered.	Baseline, pre-intervention and immediately following intervention.
Other	Rate of adverse events/complications related to ESPB and TEA	Track adverse events/complications related to ESPB and TEA such as pneumothorax, pneumonia, infection at catheter site, DVT, pulmonary embolism, urinary retention, hypotension, spinal cord injury, systemic anesthetic toxicity, epidural hematoma, and loss of motor function.	Duration of hospital stay up to 7 days.
Other	Dermatome levels with analgesia	Determine dermatome levels with analgesia using via cold sensory.	Immediately following infusion.
Other	Dermatome levels with analgesia	Determine dermatome levels with analgesia using via cold sensory.	30 minutes after infusion.
Other	Dermatome levels with analgesia	Determine dermatome levels with analgesia using via cold sensory.	Once a day in the morning, after intervention. They will be checked until the catheter is removed, which will be 7 days at the longest.
Other	Risk assessment profile (RAP) score	Standard trauma protocol includes all trauma inpatients getting a risk assessment profile (RAP) score. A RAP score <5 needs no additional monitoring. A RAP score >/= 5 gets anti-Xa monitoring (4 hrs after 3rd consecutive dose with goal parameters 0.2-0.4). A RAP score >/= 11 gets Anti-Xa monitoring plus weekly lower extremity dopplers ultrasound. This data will be in the EMR as it is standard protocol currently.	After patient discharge up to 7 days
Other	The time spent in the intensive care unit (ICU)	Total time spent in ICU	Duration of hospital stay, up to 7 days.
Other	Total length of hospital stay	Amount of time each subject spends in the hospital before discharge.	Up to 7 days.
Other	Confusion assessment method (CAM-ICU)	Scores will be charted daily and reviewed in the EMR to determine if differences in delirium are present for patients receiving TEA versus ESPB	Daily during hospital stay up to 7 days.
Other	Richmond Agitation-Sedation Scale (RASS)	Scores will be charted daily and reviewed in the EMR to determine if differences in sedation are present for patients receiving TEA versus ESPB. The scale ratings range from +4 (combative/violent/immediate danger) to -5 (unarousable).	Daily during hospital stay up to 7 days.
Other	FiO2 and time on a ventilator	Will be compared between ESPB and TEA. These values are monitored in the EMR and will be reviewed from the EMR.	Duration of hospital stay, up to 7 days.
Other	Participant satisfaction assessed on a 5 pt. scale	Assess participant satisfaction of the ESPB and TEA for MRF pain management on a 5 pt scale with 0 being "unsatisfied" and 4 being "very satisfied".	Daily during hospital stay, up to 7 days.
Other	Pain scores	Pain scores are tracked in the EMR at multiple times during the day. These will be utilized to compare morning and evening charted pain scores to the ones obtained during the morning data collection	Duration of hospital stay, up to 7 days.
Primary	MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.	Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.	24 hours after catheter placement
Primary	MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.	Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.	72 hours after catheter placement
Secondary	Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.	Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis.	After patient discharge up to 7 days