Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

NCT04140396 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 53087
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours

  MME = morphine milligram equivalent

  After 24 hours of treatment

Secondary Outcomes (7)

• Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs

  After 48 hours of treatment

• Pain Score

  Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion

• Incentive Spirometry Volumes

  Pre-infusion baseline and 24 hours post-infusion

• PIC Score

  Time 0, 24 hours, 48 hour, and 72 hours.

• Length of Hospital Stay

  29 hours

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Participants will receive placebo infusion consisting of normal saline

Drug: Saline infusion

Active Comparator

ACTIVE COMPARATOR

Participants will receive a lidocaine infusion

Drug: Lidocaine infusion

Interventions

Saline infusion DRUG

Normal saline infusion at 10mL/hour

Placebo Comparator

Lidocaine infusion DRUG

Lidocaine infusion at 1.0mg/kg/hr

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Healthcare

Stanford, California, 94304, United States

Location

Related Publications (4)

• 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.

  PMID: 10969322 BACKGROUND

• 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.

  PMID: 16269301 BACKGROUND

• 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.

  PMID: 24612969 BACKGROUND

• 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.

  PMID: 21256488 BACKGROUND

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Limitations and Caveats

This study did not meet its planned enrollment size and did not achieve statistical significance as prespecified in the study protocol.

Results Point of Contact

• Title: Chi-Ho Ban Tsui
• Organization: Stanford University

bantsui@stanford.edu

(650) 200-9107

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 25, 2019
• Study Start: February 10, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Locations

US (1)