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

Primary Purpose

Rib Fractures

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine IV Infusion
2% Lidocaine via ESPB
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Treatment Arm

Arm Description

1.0mg/kg/hr IV lidocaine infusion

10 mL of 2% lidocaine via ESPB

Outcomes

Primary Outcome Measures

OME consumption at 24 hours of treatment.
Oral morphine equivalent consumption at 24 hours of treatment

Secondary Outcome Measures

OME at 48 hrs
Oral morphine equivalent consumption at 48 hours of treatment
Pain Score
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
Incentive spirometry volumes (volume of 0 - 5000 mL)
An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
PIC score
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
Length of hospital stay
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+)
Inflammatory biomarkers
Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
Rates of pulmonary complications
We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen

Full Information

First Posted
December 23, 2020
Last Updated
April 17, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04707183
Brief Title
Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
Acronym
Rib Fract ESP
Official Title
Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
1.0mg/kg/hr IV lidocaine infusion
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
10 mL of 2% lidocaine via ESPB
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV Infusion
Other Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.
Intervention Type
Drug
Intervention Name(s)
2% Lidocaine via ESPB
Intervention Description
10 ml of 2% lidocaine will be infused through ESPB in treatment group
Primary Outcome Measure Information:
Title
OME consumption at 24 hours of treatment.
Description
Oral morphine equivalent consumption at 24 hours of treatment
Time Frame
Up to 24 hours of treatment
Secondary Outcome Measure Information:
Title
OME at 48 hrs
Description
Oral morphine equivalent consumption at 48 hours of treatment
Time Frame
Up to 48 hours of treatment
Title
Pain Score
Description
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
Time Frame
Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
Title
Incentive spirometry volumes (volume of 0 - 5000 mL)
Description
An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
Time Frame
Time 0, 24 hours, 48 hour, and 72 hours
Title
PIC score
Description
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
Time Frame
Time 0, 24 hours, 48 hour, and 72 hours.
Title
Length of hospital stay
Description
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+)
Time Frame
Up to 10 days
Title
Inflammatory biomarkers
Description
Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
Time Frame
Time 0, 24 hours, and 48 hour
Title
Rates of pulmonary complications
Description
We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen
Time Frame
Will be assessed up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Tsui, MD
Phone
(650) 200-9107
Email
bantsui@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chynna Villanueva, BS, RN
Email
chynnav@stanford.edu
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Tsui, MD
Phone
650-200-9107
Email
bantsui@stanford.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
10969322
Citation
Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
Results Reference
background
Links:
URL
http://epostersonline.com/ASRAFALL17/node/108
Description
Aggarwal A. A Role for Peripheral Intravenous Lidocaine Infusion for Rib Fracture Pain Management. Poster presented at: ASRA 16th Annual Pain Medicine Meeting of the Society of Regional Anesthesia and Pain Medicine; Nov 16-18, 2017; Lake Buena Vista, FL.

Learn more about this trial

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

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