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Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

NCT ID: NCT04140396

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2020-11-09

Brief Summary

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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.

Detailed Description

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Conditions

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Rib Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo Comparator

Participants will receive placebo infusion consisting of normal saline

Group Type PLACEBO_COMPARATOR

Saline infusion

Intervention Type DRUG

Normal saline infusion at 10mL/hour

Active Comparator

Participants will receive a lidocaine infusion

Group Type ACTIVE_COMPARATOR

Lidocaine infusion

Intervention Type DRUG

Lidocaine infusion at 1.0mg/kg/hr

Interventions

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Saline infusion

Normal saline infusion at 10mL/hour

Intervention Type DRUG

Lidocaine infusion

Lidocaine infusion at 1.0mg/kg/hr

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Chi-Ho Ban Tsui

Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Healthcare

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10969322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16269301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24612969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21256488 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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53087

Identifier Type: -

Identifier Source: org_study_id