Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures

NCT03574376 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 1146837-2
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Management of traumatic rib fractures continues to be a challenge for trauma surgeons. Currently, many analgesic options are available to patients suffering from rib fractures. Formulations currently used for conventional intercostal nerve blocks (CINB) are relatively safe, do not require additional equipment or specialized anesthesia personnel, do not require catheter repositioning, and provide improved analgesia immediately over the aforementioned systemic therapies. A goal of these authors to introduce an additional safe option for extended local analgesia in the setting of multiple rib fractures given the inconclusive evidence supporting or refuting the current standard of care

Conditions

Trauma; Trauma Injury; Pain, Acute

Keywords

Rib trauma, intercostal nerve block, liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• Change in pain relief

  Quality of analgesia provided measured by numeric grading pain scale assessment every 24 hours over a 96-hour period. Pain will be rated using the Numerical Rating Scale, ranging from 0-10. Zero represents "no pain"; worsening pain signified by increasing reported numbers with 10 being the upper limit and the "worst pain possible". Only the numbers can be answers, meaning that there are only 11 possible answers on the 0-10 scale.

  96 hours

Secondary Outcomes (11)

• Quantity of pain medication

  96 hours

• Length of pain medication

  every 24hours for 96hours

• Pulmonary function

  96 hours

• Supplemental oxygen

  96 hours

• Oxygen saturation

  96 hours

Study Arms (2)

Bupivacaine Liposome Injection [Exparel]

ACTIVE COMPARATOR

Patients will receive a nerve block with a medication called liposomal bupivacaine, also called Exparel. Once assigned, a University of Illinois surgeon, or resident surgeon, will administer the nerve block. The nerve block is expected to provide pain relief from 72 to 96 hours. During this time, patients may request oral or intravenous pain medication for breakthrough pain. Patients will remain in the hospital until discharged by the attending physician.

Drug: Bupivacaine Liposome Injection

Epidural 0.125% bupivicaine

ACTIVE COMPARATOR

Patients will receive pain relief through a 0.125% bupivacaine epidural in the upper back by an assigned anesthesiologist. This epidural will remain in place for an uncertain amount of time. The decision to remove the epidural will be determined by the physicians and will be based on level of pain and injury. However, pain data will only be recorded by the research team for no longer than 96 hours after the epidural is placed. Patients are able to request intravenous and oral pain medications for breakthrough pain. After the epidural is removed, they will remain in the hospital until discharged by the attending physician.

Drug: Bupivacaine

Interventions

Bupivacaine Liposome Injection DRUG

Under ultrasound guidance, corresponding ribs will be identified. 3-5 ml of a 1.3% (13.3 mg/mL) of liposomal bupivacaine will be drawn into a syringe with a 1.5-in, 22-gauge needle. The needle will then be advanced 20° cephalad to the skin 3-4 cm lateral to midline at the level of each fractured rib, and 1-2 ribs levels above and below injury. The needle will be advanced 3 mm below the inferior margin of the rib, placing the tip in the space containing the neurovascular bundle. Following negative aspiration for blood or air, 3-5 mL of local anesthetic will be infused and the needle withdrawn. No more than 266 mg, or 20 ml, of the 1.3% (13.3 mg/mL) liposomal bupivacaine solution will be injected

Also known as: Exparel

Bupivacaine Liposome Injection [Exparel]

Bupivacaine DRUG

The anesthesia department will manage CEA. If possible, the patient will be in the sitting position. The skin will be prepped with chlorhexidine and sterilely draped. 3 mL of lidocaine 1% will be infiltrated the closest interspace to the rib fractures between T4 -T12. A Touhy needle will be inserted, the epidural space identified by loss of resistance technique. An epidural catheter will then be inserted to a depth of 12cm. 3 mL of test solution with lidocaine 1.5% with epinephrine, 1:200,000 will be injected with continuous EKG and SpO2 monitoring. Delivery of a 0.125% bupivacaine solution be continuously infused and titrated based on the patient's clinical status

Also known as: bupivacaine Hcl

Epidural 0.125% bupivicaine

Eligibility Criteria

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

You may qualify if:

• All patients 18 years of age or older suffering 3 or more rib fractures treated by University of Illinois College of Medicine at Peoria (UICOMP) attending or resident physicians at OSF St. Francis Medical Center (OSFMC) are potentially eligible for enrollment in the trial.

You may not qualify if:

• Patients with any of the following will not be eligible since they are contraindications to CEA, LBINB, or both:
• Intracranial hemorrhage
• Fever \>101 degrees Fahrenheit for ≥ 1 hour(s)
• Rash at site of catheter insertion or administration of nerve block
• Hemodynamic instability
• Spinal cord injury
• Vertebral fractures
• Allergy to bupivacaine
• Systemic therapeutic anticoagulation required for duration of hospital admission 20
• Altered mental status without medical decision maker to provide consent
• Patients without the capacity to consent or the lack of a medical decision maker to consent
• Patients that are pregnant
• Legally confined patients.

Sponsors & Collaborators

• Chadrick Evans: lead
• University of Illinois College of Medicine at Peoria: collaborator
• OSF Healthcare System: collaborator

Study Sites (1)

Osf St Francis Medical Center

Peoria, Illinois, 61604, United States

RECRUITING

Related Publications (20)

• Ahn Y, Gorlinger K, Alam HB, Eikermann M. Pain-associated respiratory failure in chest trauma. Anesthesiology. 2013 Mar;118(3):701-8. doi: 10.1097/ALN.0b013e318283996b. No abstract available.

  PMID: 23403516 RESULT

• Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.

  PMID: 21256488 RESULT

• Horlocker TT, Wedel DJ, Rowlingson JC, Enneking FK. Executive summary: regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition). Reg Anesth Pain Med. 2010 Jan-Feb;35(1):102-5. doi: 10.1097/AAP.0b013e3181c15dd0. No abstract available.

  PMID: 20048659 RESULT

• 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.

  PMID: 27533913 RESULT

• Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.

  PMID: 25912739 RESULT

• Nosotti M, Rosso L, Tosi D, Palleschi A, Mendogni P, Righi I, Marenghi C, Santambrogio L. Preventive analgesia in thoracic surgery: controlled, randomized, double-blinded study. Eur J Cardiothorac Surg. 2015 Sep;48(3):428-33; discussion 434. doi: 10.1093/ejcts/ezu467. Epub 2014 Dec 18.

  PMID: 25527168 RESULT

• 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

• Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.

  PMID: 26507422 RESULT

• Karmakar MK, Critchley LA, Ho AM, Gin T, Lee TW, Yim AP. Continuous thoracic paravertebral infusion of bupivacaine for pain management in patients with multiple fractured ribs. Chest. 2003 Feb;123(2):424-31. doi: 10.1378/chest.123.2.424.

  PMID: 12576361 RESULT

• Battle CE, Hutchings H, James K, Evans PA. The risk factors for the development of complications during the recovery phase following blunt chest wall trauma: a retrospective study. Injury. 2013 Sep;44(9):1171-6. doi: 10.1016/j.injury.2012.05.019. Epub 2012 Jun 12.

  PMID: 22695321 RESULT

• 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 RESULT

• Britt T, Sturm R, Ricardi R, Labond V. Comparative evaluation of continuous intercostal nerve block or epidural analgesia on the rate of respiratory complications, intensive care unit, and hospital stay following traumatic rib fractures: a retrospective review. Local Reg Anesth. 2015 Oct 27;8:79-84. doi: 10.2147/LRA.S80498. eCollection 2015.

  PMID: 26604819 RESULT

• Byun JH, Kim HY. Factors affecting pneumonia occurring to patients with multiple rib fractures. Korean J Thorac Cardiovasc Surg. 2013 Apr;46(2):130-4. doi: 10.5090/kjtcs.2013.46.2.130. Epub 2013 Apr 9.

  PMID: 23614099 RESULT

• 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 RESULT

• Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086.

  PMID: 24458051 RESULT

• Duch P, Moller MH. Epidural analgesia in patients with traumatic rib fractures: a systematic review of randomised controlled trials. Acta Anaesthesiol Scand. 2015 Jul;59(6):698-709. doi: 10.1111/aas.12475. Epub 2015 Feb 13.

  PMID: 25683770 RESULT

• 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 RESULT

• Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.

  PMID: 25210700 RESULT

• Ilfeld BM, Malhotra N, Furnish TJ, Donohue MC, Madison SJ. Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study. Anesth Analg. 2013 Nov;117(5):1248-56. doi: 10.1213/ANE.0b013e31829cc6ae.

  PMID: 24108252 RESULT

• Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

  PMID: 26204387 RESULT

Related Links

• Management of Antithrombotic Therapy for Neuraxial and Peripheral Nerve Procedures

MeSH Terms

Conditions

Wounds and Injuries; Accidental Injuries; Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Chadrick R Evans, MD

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chadrick R Evans, MD

CONTACT

309-655-2383; cevans@peoriasurgical.com

Jonathan Jou, MD

CONTACT

312-835-0993; jjou3@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No participants are blinded to treatment arms. Patients and investigators are aware of which patients are assigned to each treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Surgical ICU and Trauma

Model Details: This is a two arm, randomized trial. Patients suffering multiple traumatic rib fractures will be offered CEA or LBINB. As the current standard of care, CEA will serve as the control, and outcomes measured in patients receiving LBINB will be statistically evaluated relative to the CEA control group. All patients will receive standardized NSAID and opioid analgesia protocol for break through pain, as well as standardized routines for pulmonary hygiene and physiotherapy.

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 2, 2018
• Study Start: August 29, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)