Trial Outcomes & Findings for IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery (NCT NCT01180660)

Results Overview

Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high. The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

24 hours

Results posted on

2014-08-07

Participant Flow

51 subjects were randomized and 50 completed the study. Subjects were enrolled consecutively from August 2010 through October 2012.

60 subjects were assessed for eligibility and 9 were excluded because they did not meet inclusion criteria n=3 or the subject refused n=6. 51 subjects were randomized to the study

Participant milestones

Participant milestones
Measure	Lidocaine Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Overall Study STARTED	25	26
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Overall Study Changed to open surgery	1	0

Baseline Characteristics

IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=25 Participants Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo n=26 Participants Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	26 Participants n=4 Participants	51 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	23 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	25 participants n=93 Participants	26 participants n=4 Participants	51 participants n=27 Participants
Body Mass Index	47 Unit of measure (kg/m2) n=93 Participants	48 Unit of measure (kg/m2) n=4 Participants	47 Unit of measure (kg/m2) n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high. The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.

Outcome measures

Outcome measures
Measure	Lidocaine n=24 Participants Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo n=26 Participants Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Quality of Recovery 40 on the Day After Surgery	165 units on scale 40 (low) - 200 (high) Interval 151.0 to 170.0	146 units on scale 40 (low) - 200 (high) Interval 130.0 to 169.0

SECONDARY outcome

Timeframe: 24 hours post surgery

24 hour total opioid consumption using IV morphine equivalents

Outcome measures

Outcome measures
Measure	Lidocaine n=24 Participants Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo n=26 Participants Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
24 Hour Total Opioid Consumption	26 miligrams Interval 19.0 to 46.0	36 miligrams Interval 24.0 to 65.0

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine n=24 participants at risk Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Placebo n=26 participants at risk Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Gastrointestinal disorders Nausea	20.8% 5/24 • Number of events 5 • 24 hours after surgery	53.8% 14/26 • Number of events 14 • 24 hours after surgery

Additional Information

Gildasio De Oliveira MD

Northwestern University

Phone: 312-472-3573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place