Lidocaine Infusions for Rib Fractures

NCT03571919 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 44300
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.

Conditions

Rib Fracture Multiple; Trauma Chest; Pain, Acute

Keywords

Lidocaine infusion

Outcome Measures

Primary Outcomes (1)

• Opioid pain medicine usage

  Total opioid pain medicine usage

  Average per 24 hours

Secondary Outcomes (6)

• PCA requirements

  5 days

• Pain score

  5 days

• Length of stay

  5 days

• Respiratory failure

  5 days

• Death

  up to 30 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.

Drug: Saline infusion

Lidocaine

ACTIVE COMPARATOR

Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.

Drug: Lidocaine infusion

Interventions

Lidocaine infusion DRUG

Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr

Lidocaine

Saline infusion DRUG

Intravenous bolus of saline and then infusion

Control

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 or older with 2+ rib fractures or \> 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI \> 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)

You may not qualify if:

• Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS \< 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR \< 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic
• Enrollment in other study that may affect the results of this study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Thoracic Injuries; Acute Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff Choi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Michael Y Lin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Immediate care providers (nurses, primary teams) will be blinded; however, lidocaine levels will be monitored by the acute pain service, a consulting team providing direct care to the patient, who will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: June 15, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)