TraumaPhase 4NCT03574376
Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures
A Phase 4 study testing Bupivacaine Liposome Injection and Bupivacaine in people with Trauma and Trauma Injury, run by Chadrick Evans at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Trauma Injury, Pain, Acute
- What is being tested?
- Bupivacaine Liposome Injection and Bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 1 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Osf St Francis Medical Center
Peoria, Illinois, 61604
Chadrick R Evans, MD, 309-655-3971, cevans@peoriasurgical.com
Jonathan Jou, MD, 312-835-0993, jjou3@uic.edu
About this study
Official title: Protocol for a Single Center Randomized Controlled Trial of Liposomal Bupivacaine Intercostal Nerve Blockade Versus Continuous Thoracic Epidural for Regional Analgesia in Patients With Multiple Rib Fractures
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
Read the detailed description
The objective of this study is to quantify and draw inferences on the efficacy of a multiple level liposomal bupivacaine intercostal nerve blockade (LBINB) in patients with multiple traumatic rib fractures.
The primary objective is to assess the quality and duration of analgesia based on numeric grading pain scale, improvement in pulmonary function parameters, reduction pulmonary complications, and duration of hospitalization in patients receiving LBINBs relative to those receiving the current standard of care, CEA, in patients recovering from multiple traumatic rib fractures.
The secondary objective of this study is to assess cost and rate of complications associated with LBINB relative to CEA.
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.
Indications for CEA and LBINB in this study include patients suffering from traumatic thoracic injury with greater than or equal to 3 fractured ribs
- Conditions
- Trauma, Trauma Injury, Pain, Acute
- Being tested
- Bupivacaine Liposome Injection, Bupivacaine
- Keywords
- Rib trauma, intercostal nerve block, liposomal bupivacaine
- Medical subject headings
- Wounds and Injuries, Accidental Injuries, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome InjectionDrug
Also called Exparel
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
BupivacaineDrug
Also called bupivacaine Hcl
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 hours
Secondary outcomes (11)
Quantity of pain medication
Amount of breakthrough analgesia required in morphine equivalents
Measured: 96 hours
Length of pain medication
Duration of analgesia provided measured by numeric grading pain scale assessment every 24hours. 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.
Measured: every 24hours for 96hours
Pulmonary function
Pulmonary function measured by incentive spirometry
Measured: 96 hours
Supplemental oxygen
Supplemental oxygen requirements
Measured: 96 hours
Oxygen saturation
Oxygen saturation levels
Measured: 96 hours
Pulmonary complications
Development of pulmonary complications: atelectasis, pneumonia, respiratory failure
Measured: 96 hours
Ventilator
Ventilator days
Measured: 96 hours
Overall length of stay
Length of stay
Measured: 96 hours
ICU stay
Duration of ICU days
Measured: 96 hours
Costs
Costs associated with administration of epidural vs exparel
Measured: 96 hours
Overall complication rate
Overall rate of complications associated with epidural vs exparel
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start29 Aug 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chadrick Evans
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria, OSF Healthcare System
- Responsible party
- Sponsor-investigator, Chadrick Evans, OSF Healthcare System
- Investigators
- Chadrick R Evans, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574376
- Sponsor's protocol ID
- 1146837-2
- Status last verified
- Mar 2020
- First submitted
- 1 Jun 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23403516Battle 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.
PubMed 21256488Horlocker 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.
PubMed 20048659Galvagno 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.
PubMed 27533913Rice 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.
PubMed 25912739Nosotti 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.
PubMed 25527168Mohta 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.
PubMed 19359920Khalil 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.
PubMed 26507422Karmakar 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.
PubMed 12576361Battle 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.
PubMed 22695321Brasel 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.
PubMed 16625122Britt 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.
PubMed 26604819Byun 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.
PubMed 23614099Carrier 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.
PubMed 19247744Dehghan 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.
PubMed 24458051
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Single Center Randomized Controlled Trial of Liposomal Bupivacaine Intercostal Nerve Blockade Versus Continuous Thoracic Epidural for Regional Analgesia in Patients With Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT03574376
- Acronym / sponsor ID
- 1146837-2
- Conditions
- Trauma, Trauma Injury, Pain, Acute
- Keywords
- Rib trauma, intercostal nerve block, liposomal bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Chadrick EvansUniversity, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria, OSF Healthcare System
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The objective of this study is to quantify and draw inferences on the efficacy of a multiple level liposomal bupivacaine intercostal nerve blockade (LBINB) in patients with multiple traumatic rib fractures.
The primary objective is to assess the quality and duration of analgesia based on numeric grading pain scale, improvement in pulmonary function parameters, reduction pulmonary complications, and duration of hospitalization in patients receiving LBINBs relative to those receiving the current standard of care, CEA, in patients recovering from multiple traumatic rib fractures.
The secondary objective of this study is to assess cost and rate of complications associated with LBINB relative to CEA.
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.
Indications for CEA and LBINB in this study include patients suffering from traumatic thoracic injury with greater than or equal to 3 fractured ribs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Liposome Injection [Exparel] | Active comparator | Drug: Bupivacaine Liposome InjectionPatients 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. |
| Epidural 0.125% bupivicaine | Active comparator | Drug: BupivacainePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- Patients with any of the following will not be eligible since they are contraindications to CEA, LBINB, or both:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Liposome InjectionAlso: ExparelUnder 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 | Drug | Bupivacaine Liposome Injection [Exparel] |
| BupivacaineAlso: bupivacaine HclThe 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 | Drug | Epidural 0.125% bupivicaine |
Primary outcome
Change in pain relief
Time frame: 96 hours
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.
11 secondary outcomes
Quantity of pain medication
Time frame: 96 hours
Length of pain medication
Time frame: every 24hours for 96hours
Pulmonary function
Time frame: 96 hours
Supplemental oxygen
Time frame: 96 hours
Oxygen saturation
Time frame: 96 hours
Pulmonary complications
Time frame: 96 hours
Ventilator
Time frame: 96 hours
Overall length of stay
Time frame: 96 hours
ICU stay
Time frame: 96 hours
Costs
Time frame: 96 hours
Overall complication rate
Time frame: 96 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Results publication: PubMed 23403516Ahn 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.
- Results publication: PubMed 21256488Battle 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.
- Results publication: PubMed 20048659Horlocker 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.
- Results publication: PubMed 27533913Galvagno 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.
- Results publication: PubMed 25912739Rice 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.
- Results publication: PubMed 25527168Nosotti 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.
- Results publication: PubMed 19359920Mohta 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.
- Results publication: PubMed 26507422Khalil 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.
- Results publication: PubMed 12576361Karmakar 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.
- Results publication: PubMed 22695321Battle 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.
- Results publication: PubMed 16625122Brasel 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.
- Results publication: PubMed 26604819Britt 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.
- Management of Antithrombotic Therapy for Neuraxial and Peripheral Nerve ProceduresLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chadrick R Evans, MD principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Liposome Injection and Bupivacaine in people with Trauma and Trauma Injury, run by Chadrick Evans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chadrick R Evans, MD (309-655-2383, cevans@peoriasurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain relief (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574376, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.