Trial Outcomes & Findings for Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies (NCT NCT02623803)

NCT ID: NCT02623803

Last Updated: 2019-04-16

Results Overview

Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: baseline - arrival at the PACU
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Treatment Group lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Study STARTED	25	23
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment Group n=25 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=23 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W	Total n=48 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 10.5 • n=25 Participants	65.1 years STANDARD_DEVIATION 13.3 • n=23 Participants	65.7 years STANDARD_DEVIATION 67.0 • n=48 Participants
Sex: Female, Male Female	10 Participants n=25 Participants	14 Participants n=23 Participants	24 Participants n=48 Participants
Sex: Female, Male Male	15 Participants n=25 Participants	9 Participants n=23 Participants	24 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	23 participants n=23 Participants	48 participants n=48 Participants
Body Mass Index	26.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=25 Participants	28.0 kg/m^2 STANDARD_DEVIATION 5.4 • n=23 Participants	27.1 kg/m^2 STANDARD_DEVIATION 4.8 • n=48 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification ASA II	3 Participants n=25 Participants	6 Participants n=23 Participants	9 Participants n=48 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification ASA III	22 Participants n=25 Participants	17 Participants n=23 Participants	39 Participants n=48 Participants

PRIMARY outcome

Timeframe: baseline - arrival at the PACU

Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=20 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=18 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Pain in Postoperative Period	1.6 score on a scale Standard Deviation 3.2	2.7 score on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: up to 4 hours post-operatively

Total opioid consumption in PACU converted to morphine equivalents in mg.

Outcome measures

Measure	Treatment Group n=23 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=18 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Opioid Consumption	3.9 mg Standard Deviation 4.1	6.7 mg Standard Deviation 7.6

SECONDARY outcome

Timeframe: baseline - arrival at the PACU

Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=25 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=23 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain at Rest	2.1 score on a scale Standard Deviation 3.6	2.6 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: baseline - arrival at the PACU

Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=18 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=15 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain With Coughing	2.3 score on a scale Standard Deviation 3.9	2.5 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 30 minutes after arrival to PACU

Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=19 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=18 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Pain	3.3 score on a scale Standard Deviation 3.1	5.3 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 30 minutes after arrival to PACU

Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=24 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=22 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain at Rest	3.3 score on a scale Standard Deviation 3.6	5.1 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 30 minutes after arrival to PACU

Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=19 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=16 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain With Coughing	4.3 score on a scale Standard Deviation 3.9	5.8 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: approximately 12 hours post-operatively

Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=22 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=17 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Pain	4.4 score on a scale Standard Deviation 2.7	5.4 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: approximately 12 hours post-operatively

Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=25 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=20 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain at Rest	4.0 score on a scale Standard Deviation 3.0	5.0 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: approximately 12 hours post-operatively

Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=13 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=9 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain With Coughing	4.7 score on a scale Standard Deviation 3.1	7.6 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: post-operative day 1 at 1am

Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=20 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=19 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Pain	5.1 score on a scale Standard Deviation 2.0	5.5 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: post-operative day 1 at 1 am

Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=25 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=23 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain at Rest	4.0 score on a scale Standard Deviation 3.1	4.6 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: post-operative day 1 at 1 am

Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=12 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=9 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain With Coughing	5.4 score on a scale Standard Deviation 3.4	7.1 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: post-operative day 1 at 1 pm

Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=20 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=18 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Overall Pain	4.8 score on a scale Standard Deviation 1.8	4.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: post-operative day 1 at 1 pm

Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=24 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=22 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain at Rest	4.0 score on a scale Standard Deviation 2.3	4.8 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: post-operative day 1 at 1 pm

Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Treatment Group n=11 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=8 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Pain With Coughing	5.4 score on a scale Standard Deviation 2.7	5.8 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: up to 3 weeks postoperatively

Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.

Outcome measures

Measure	Treatment Group n=23 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=23 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Length of Time to First Flatus	3.9 days Standard Deviation 6.6	2.7 days Standard Deviation 1.2

SECONDARY outcome

Timeframe: up to 3 weeks postoperatively

Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.

Outcome measures

Measure	Treatment Group n=18 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=18 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Length of Time to First Bowel Movement	5.8 days Standard Deviation 7.7	5.2 days Standard Deviation 6.0

SECONDARY outcome

Timeframe: up to 24 hours post-operatively

Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.

Outcome measures

Measure	Treatment Group n=25 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=23 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Total Opioid Consumption	7.4 mg Standard Deviation 5.4	7.9 mg Standard Deviation 6.4

SECONDARY outcome

Timeframe: Day 15 post-operatively

This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response.

Outcome measures

Measure	Treatment Group n=20 Participants lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine	Control Group n=21 Participants placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W
Quality of Recovery Severe pain	9.4 score on a scale Standard Deviation 1.8	8.8 score on a scale Standard Deviation 2.2
Quality of Recovery Nausea or vomiting	8.6 score on a scale Standard Deviation 2.3	8.2 score on a scale Standard Deviation 2.6
Quality of Recovery Feeling worried or anxious	7.7 score on a scale Standard Deviation 3.0	7.6 score on a scale Standard Deviation 2.5
Quality of Recovery Feeling sad or depressed	8.4 score on a scale Standard Deviation 2.6	7.8 score on a scale Standard Deviation 3.1
Quality of Recovery Able to breathe easily	9.1 score on a scale Standard Deviation 1.8	8.7 score on a scale Standard Deviation 1.8
Quality of Recovery Been able to enjoy food	6.2 score on a scale Standard Deviation 3.7	5.4 score on a scale Standard Deviation 2.9
Quality of Recovery Feeling rested	7.2 score on a scale Standard Deviation 1.8	6.0 score on a scale Standard Deviation 2.2
Quality of Recovery Have had a good sleep	7.1 score on a scale Standard Deviation 1.9	6.6 score on a scale Standard Deviation 2.4
Quality of Recovery Able to look after personal toliet and hygiene	9.2 score on a scale Standard Deviation 2.3	8.8 score on a scale Standard Deviation 2.3
Quality of Recovery Able to communicate with family or friends	9.6 score on a scale Standard Deviation 1.1	9.3 score on a scale Standard Deviation 1.4
Quality of Recovery Getting support from hospital doctors and nurse	8.8 score on a scale Standard Deviation 3.1	9.5 score on a scale Standard Deviation 0.7
Quality of Recovery Able to return to work or usual home activities	5.4 score on a scale Standard Deviation 3.5	4.9 score on a scale Standard Deviation 3.2
Quality of Recovery Feeling comfortable and in control	7.1 score on a scale Standard Deviation 2.5	6.7 score on a scale Standard Deviation 2.7
Quality of Recovery Having a feeling of general well-being	7.5 score on a scale Standard Deviation 2.2	6.7 score on a scale Standard Deviation 2.2
Quality of Recovery Moderate pain	7.9 score on a scale Standard Deviation 2.5	6.6 score on a scale Standard Deviation 2.7

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Dr. Elird Bojaxhi

Mayo Clinic

Phone: 904-956-3327

Email: bojaxhi.elrid@mayo.edu

Results disclosure agreements

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