Trial Outcomes & Findings for Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients (NCT NCT02219321)

Results Overview

Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

Immediately after continuous 4-hours Intravenous lidocaine infusion

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Infusion A continuous intravenous infusion of lidocaine Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours	Saline Infusion A continuous intravenous infusion of saline Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Infusion n=1 Participants A continuous intravenous infusion of lidocaine Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours	Saline Infusion n=2 Participants A continuous intravenous infusion of saline Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours	Total n=3 Participants Total of all reporting groups
Age, Continuous	51 years n=93 Participants	57 years n=4 Participants	55 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	2 participants n=4 Participants	0 participants n=27 Participants

PRIMARY outcome

Timeframe: Immediately after continuous 4-hours Intravenous lidocaine infusion

Population: Chronic pain patients with opioid precription

Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)

Outcome measures

Outcome measures
Measure	Lidocaine Infusion n=1 Participants A continuous intravenous infusion of lidocaine Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours	Saline Infusion n=2 Participants A continuous intravenous infusion of saline Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Intensity of Pain	8 units on a scale 0 to 10 Interval 7.0 to 8.0	3 units on a scale 0 to 10 Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Immediately after Lidocaine Infusion

The time to withdraw at the Cold Pressor Task immediately after 4-hours intravenous continuous lidocaine infusion

Outcome measures

Outcome measures
Measure	Lidocaine Infusion n=1 Participants A continuous intravenous infusion of lidocaine Lidocaine infusion: Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours	Saline Infusion n=2 Participants A continuous intravenous infusion of saline Saline infusion: A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Withdrawal Time (Seconds)	61 seconds Interval 61.0 to 61.0	41.5 seconds Interval 24.0 to 59.0

Adverse Events

Lidocaine Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Infusion

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

Enas Kandil

University of Texas Southwestern Medical Center

Phone: 214-648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place