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Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Primary Purpose

Rib Fractures

Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Saline infusion
Lidocaine infusion
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 - undefined (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 Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Comparator

Active Comparator

Arm Description

Participants will receive placebo infusion consisting of normal saline

Participants will receive a lidocaine infusion

Outcomes

Primary Outcome Measures

OME consumption at 24 hours
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
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 things like ARDS, pneumonia, aspiration, empyema, etc

Full Information

First Posted
October 16, 2019
Last Updated
April 17, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04140396
Brief Title
Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Official Title
A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Lack of personnel and lack of funding for the study drug
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium. In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain. Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.

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 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo infusion consisting of normal saline
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Participants will receive a lidocaine infusion
Intervention Type
Drug
Intervention Name(s)
Saline infusion
Intervention Description
Normal saline infusion at 10mL/hour
Intervention Type
Drug
Intervention Name(s)
Lidocaine infusion
Intervention Description
Lidocaine infusion at 1.0mg/kg/hr
Primary Outcome Measure Information:
Title
OME consumption at 24 hours
Description
oral morphine equivalent consumption at 24 hours of treatment
Time Frame
After 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
After 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
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 things like ARDS, pneumonia, aspiration, empyema, etc
Time Frame
Will be assessed up to 72 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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.
Facility Information:
Facility Name
Stanford Healthcare
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

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
PubMed Identifier
16269301
Citation
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.
Results Reference
background
PubMed Identifier
24612969
Citation
Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
Results Reference
background
PubMed Identifier
21256488
Citation
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.
Results Reference
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Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

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