Lidocaine Infusions for Rib Fractures

Pain, Acute Clinical Trial

— Lidocare  

Official title:

Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03571919
• Other study ID #: 44300
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 15, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Pain
• Fractures, Bone
• Pain, Acute
• Rib Fracture Multiple
• Rib Fractures
• Trauma Chest

Intervention

Drug:
• Lidocaine infusion
Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
• Saline infusion
Intravenous bolus of saline and then infusion

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid pain medicine usage	Total opioid pain medicine usage	Average per 24 hours
Secondary	PCA requirements	Percentage of patients requiring PCA	5 days
Secondary	Pain score	Average pain scores	5 days
Secondary	Length of stay	Average length of stay in ICU and hospital	5 days
Secondary	Respiratory failure	Rates of pneumonia or other respiratory failure (pneumonia defined as (1) new pulmonary infiltrate on chest X-ray and (2) two of three of the following: (a) productive cough (b) WBC > 12,000 and (c) temperature > 38.0)	5 days
Secondary	Death	Mortality rate between two groups	up to 30 days
Secondary	Mobility	Highest level of mobility on hospital day #2	2 days