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Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia (Rib Fract ESP)

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ClinicalTrials.gov Identifier: NCT04707183
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Brief Summary:

Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values.

The goal of this study is to compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures.

The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers.

The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.


Condition or disease Intervention/treatment Phase
Rib Fractures Drug: Lidocaine IV Infusion Drug: 2% Lidocaine via ESPB Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Arm
1.0mg/kg/hr IV lidocaine infusion
Drug: Lidocaine IV Infusion
Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.
Other Name: Lidocaine

Experimental: Treatment Arm
10 mL of 2% lidocaine via ESPB
Drug: 2% Lidocaine via ESPB
10 ml of 2% lidocaine will be infused through ESPB in treatment group




Primary Outcome Measures :
  1. OME consumption at 24 hours of treatment. [ Time Frame: Up to 24 hours of treatment ]
    Oral morphine equivalent consumption at 24 hours of treatment


Secondary Outcome Measures :
  1. OME at 48 hrs [ Time Frame: Up to 48 hours of treatment ]
    Oral morphine equivalent consumption at 48 hours of treatment

  2. Pain Score [ Time Frame: Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration. ]
    Pain scores at rest and with cough and deep inspiration. Will use Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable

  3. Incentive spirometry volumes (volume of 0 - 5000 mL) [ Time Frame: Time 0, 24 hours, 48 hour, and 72 hours ]
    An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.

  4. PIC score [ Time Frame: Time 0, 24 hours, 48 hour, and 72 hours. ]
    PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume(set by respiratory therapist), and strong cough

  5. Length of hospital stay [ Time Frame: Up to 10 days ]
    We will record the number of days stayed at the hospital from the day of operation till the day of discharge (from 0-10, or 10+)

  6. Inflammatory biomarkers [ Time Frame: Time 0, 24 hours, and 48 hour ]
    Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)

  7. Rates of pulmonary complications [ Time Frame: Will be assessed up to 72 hours ]
    We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.

Exclusion Criteria:

  • Hemodynamically instability,
  • Mechanical ventilation,
  • Polytrauma (defined as bone or organ injury outside the thorax),
  • Pregnancy,
  • Incarceration
  • Local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block)
  • Chronic opioid use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707183


Contacts
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Contact: Ban Tsui, MD (650) 200-9107 bantsui@stanford.edu
Contact: Chynna Villanueva, BS, RN chynnav@stanford.edu

Locations
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United States, California
Stanford Health Care
Stanford, California, United States, 94305
Contact: Ban Tsui, MD    650-200-9107    bantsui@stanford.edu   
Sponsors and Collaborators
Stanford University
Additional Information:
Publications:
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Responsible Party: Chi-Ho Ban Tsui, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT04707183    
Other Study ID Numbers: 53844
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action