Trial Outcomes & Findings for Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia (NCT NCT04140396)

NCT ID: NCT04140396

Last Updated: 2023-11-30

Results Overview

MME = morphine milligram equivalent

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: After 24 hours of treatment
• Results posted on: 2023-11-30

Participant Flow

Participant milestones

Measure	Placebo Comparator Participants will receive placebo infusion consisting of normal saline.	Active Comparator Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Baseline characteristics by cohort

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 24 hours of treatment

MME = morphine milligram equivalent

Outcome measures

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours	7.5 MME Standard Deviation NA Standard deviation not calculable for n of 1

SECONDARY outcome

Timeframe: After 48 hours of treatment

Population: No data were collected for this outcome, patient was discharged prior to this time point.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Pain scores at rest rated using the Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable

Outcome measures

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Pain Score Pre-infusion baseline	1 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Pain Score 1 hour post-infusion	1 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Pain Score 10 hours post-infusion	0 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Pain Score 13 hours post-infusion	0 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Pain Score 16 hours post-infusion	4 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Pain Score 17 hours post-infusion	2 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1

SECONDARY outcome

Timeframe: Pre-infusion baseline and 24 hours post-infusion

Population: Standard deviation not calculable for n of 1

An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.

Outcome measures

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Incentive Spirometry Volumes Pre-infusion baseline	1500 mL Standard Deviation NA Standard deviation not calculable for n of 1
Incentive Spirometry Volumes 24 hours post-infusion	1500 mL Standard Deviation NA Standard deviation not calculable for n of 1

SECONDARY outcome

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

Population: Data were not collected for this outcome measure.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 29 hours

Number of hours stayed at the hospital from the day of operation till the day of discharge.

Outcome measures

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Length of Hospital Stay	29 hours Standard Deviation NA Standard deviation not calculable for n of 1

SECONDARY outcome

Timeframe: Time 0, 24 hours, and 48 hour

Population: Data were not collected for this outcome measure.

Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 29 hours

Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc.

Outcome measures

Measure	Active Comparator n=1 Participants Participants will receive a lidocaine infusion at 1.0mg/kg/hr.
Number of Pulmonary Complication Events	0 events Standard Deviation NA Standard deviation not calculable for n of 1

Adverse Events

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chi-Ho Ban Tsui

Stanford University

Phone: (650) 200-9107

Email: bantsui@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place