Trial Outcomes & Findings for Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery (NCT NCT00913003)

Results Overview

Total IV hydromorphone administered during surgery to 24 hours post surgery

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

24 hour

Results posted on

2015-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine n=11 Participants Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)	Total n=22 Participants Total of all reporting groups
Age, Continuous	50.4 Years STANDARD_DEVIATION 10.1 • n=99 Participants	48.5 Years STANDARD_DEVIATION 7.9 • n=107 Participants	49.5 Years STANDARD_DEVIATION 9.1 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	11 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	11 participants n=99 Participants	11 participants n=107 Participants	22 participants n=206 Participants

PRIMARY outcome

Timeframe: 24 hour

Total IV hydromorphone administered during surgery to 24 hours post surgery

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine n=11 Participants Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
24 Hour Hydromorphone	2.33 miligrams Standard Deviation 1.6	1.5 miligrams Standard Deviation 1.2

SECONDARY outcome

Timeframe: Immediate post operative to 48 hours

Nausea at any time during the post operative period for 48 hours

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine n=11 Participants Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
Number of Participants Experiencing Post Operative Nausea	11 Participants	11 Participants

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine n=11 Participants Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
Number of Participants Experiencing Post Operative Ileus	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=11 participants at risk Group B using saline as a placebo. Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug	Lidocaine n=11 participants at risk Group A lidocaine infusion and bolus. Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
Cardiac disorders First degree heart block	0.00% 0/11 • 14 days	9.1% 1/11 • Number of events 1 • 14 days

Additional Information

Paul Fitzgerald

Northwestern University

Phone: 312-695- 1064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place