Trial Outcomes & Findings for Lidocaine and Outpatient Gynecologic Laparoscopy (NCT NCT01250002)

NCT ID: NCT01250002

Last Updated: 2014-06-26

Results Overview

Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 24 hours post surgery
• Results posted on: 2014-06-26

Participant Flow

Subjects were recruited in the preoperative area of the hospital between November 2010 and September 2011.

All participants were assigned to groups.

Participant milestones

Measure	Group A (Study Group) Lidocaine Group A (study group) Lidocaine administration	Placebo Group B (control group) will receive the same volume of saline infusion.
Overall Study STARTED	35	35
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Group A (Study Group) Lidocaine Group A (study group) Lidocaine administration	Placebo Group B (control group) will receive the same volume of saline infusion.
Overall Study Change to open surgical procedure	4	3

Baseline Characteristics

Lidocaine and Outpatient Gynecologic Laparoscopy

Baseline characteristics by cohort

Measure	Group A (Study Group) Lidocaine n=35 Participants Group A (study group) Lidocaine administration	Placebo n=35 Participants Group B (control group) will receive the same volume of saline infusion.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.2 years STANDARD_DEVIATION 8.6 • n=5 Participants	39.1 years STANDARD_DEVIATION 9.3 • n=7 Participants	38.2 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post surgery

Population: Intent to treat.

Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).

Outcome measures

Measure	Group A (Study Group) Lidocaine n=31 Participants Group A (study group) Lidocaine administration	Placebo n=32 Participants Group B (control group) will receive the same volume of saline infusion.
Quality of Recovery 40 Score	175 units on a scale Interval 160.0 to 183.0	157.5 units on a scale Interval 142.5 to 173.5

SECONDARY outcome

Timeframe: 24 hours

opioid consumption (morphine equivalents)post operatively

Outcome measures

Measure	Group A (Study Group) Lidocaine n=31 Participants Group A (study group) Lidocaine administration	Placebo n=32 Participants Group B (control group) will receive the same volume of saline infusion.
Opioid Consumption (Morphine Equivalents)	20 mg Interval 0.0 to 30.0	30 mg Interval 15.0 to 35.0

Adverse Events

Group A (Study Group) Lidocaine

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A (Study Group) Lidocaine n=35 participants at risk Group A (study group) Lidocaine administration	Placebo n=35 participants at risk Group B (control group) will receive the same volume of saline infusion.
Gastrointestinal disorders Nausea	34.3% 12/35 • Number of events 12 • 2 Days	48.6% 17/35 • Number of events 17 • 2 Days
Gastrointestinal disorders Vomiting	22.9% 8/35 • Number of events 8 • 2 Days	28.6% 10/35 • Number of events 10 • 2 Days

Additional Information

Gildasio De Oliveira, MD

Northwestern University

Phone: 312-926-8373

Email: g-jr@northwestern.edu

Results disclosure agreements

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