Pancreatectomy
Conditions
Brief summary
The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.
Interventions
DRUGLidocaine
DRUGPlacebo D5W
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida. * Age 18 - 80 years old * American Society of Anesthesiologist (ASA) class I - III * BMI \< 40 * Ability to understand and read English
Exclusion criteria
* Not able or willing to sign consent * Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine). * History of epilepsy or currently receiving treatment for seizures * Severe hepatic insufficiency (Child-Pugh Score C) * Renal insufficiency (creatinine clearance less than 30 mL/minute) * Advance heart failure (NY Heart failure stage 3 or greater; Ejection function \<30%) * Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers * Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate * Patients with active psychiatric disorders or cognitive dysfunction * Pregnancy or lactating * Enucleation, central, and distal pancreatectomy * Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain in Postoperative Period | 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. |
| Opioid Consumption | up to 4 hours post-operatively | Total opioid consumption in PACU converted to morphine equivalents in mg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain | 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. |
| Length of Time to First Flatus | 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. |
| Pain at Rest | 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. |
| Total Opioid Consumption | up to 24 hours post-operatively | Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery. |
| Quality of Recovery | 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. |
| Length of Time to First Bowel Movement | 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. |
| Pain With Coughing | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | Control Group | Total | Treatment Group |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 13.3 | 65.7 years STANDARD_DEVIATION 67 | 66.3 years STANDARD_DEVIATION 10.5 |
| American Society of Anesthesiologists (ASA) Physical Status Classification ASA II | 6 Participants | 9 Participants | 3 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification ASA III | 17 Participants | 39 Participants | 22 Participants |
| Body Mass Index | 28.0 kg/m^2 STANDARD_DEVIATION 5.4 | 27.1 kg/m^2 STANDARD_DEVIATION 4.8 | 26.3 kg/m^2 STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 48 participants | 25 participants |
| Sex: Female, Male Female | 14 Participants | 24 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 24 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Opioid Consumption
Total opioid consumption in PACU converted to morphine equivalents in mg.
Time frame: up to 4 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Opioid Consumption | 3.9 mg | Standard Deviation 4.1 |
| Control Group | Opioid Consumption | 6.7 mg | Standard Deviation 7.6 |
p-value: 0.205Wilcoxon (Mann-Whitney)
Primary
Overall Pain in Postoperative Period
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.
Time frame: baseline - arrival at the PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Overall Pain in Postoperative Period | 1.6 score on a scale | Standard Deviation 3.2 |
| Control Group | Overall Pain in Postoperative Period | 2.7 score on a scale | Standard Deviation 1 |
p-value: 0.1459Wilcoxon (Mann-Whitney)
Secondary
Length of Time to First Bowel Movement
Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.
Time frame: up to 3 weeks postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Length of Time to First Bowel Movement | 5.8 days | Standard Deviation 7.7 |
| Control Group | Length of Time to First Bowel Movement | 5.2 days | Standard Deviation 6 |
p-value: 0.8339Wilcoxon (Mann-Whitney)
Secondary
Length of Time to First Flatus
Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.
Time frame: up to 3 weeks postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Length of Time to First Flatus | 3.9 days | Standard Deviation 6.6 |
| Control Group | Length of Time to First Flatus | 2.7 days | Standard Deviation 1.2 |
p-value: 0.5107Wilcoxon (Mann-Whitney)
Secondary
Overall Pain
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.
Time frame: post-operative day 1 at 1am
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Overall Pain | 5.1 score on a scale | Standard Deviation 2 |
| Control Group | Overall Pain | 5.5 score on a scale | Standard Deviation 2.1 |
p-value: 0.5314Wilcoxon (Mann-Whitney)
Secondary
Overall Pain
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.
Time frame: post-operative day 1 at 1 pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Overall Pain | 4.8 score on a scale | Standard Deviation 1.8 |
| Control Group | Overall Pain | 4.8 score on a scale | Standard Deviation 1.8 |
p-value: 0.9171Wilcoxon (Mann-Whitney)
Secondary
Overall Pain
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.
Time frame: 30 minutes after arrival to PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Overall Pain | 3.3 score on a scale | Standard Deviation 3.1 |
| Control Group | Overall Pain | 5.3 score on a scale | Standard Deviation 3.3 |
p-value: 0.0697Wilcoxon (Mann-Whitney)
Secondary
Overall Pain
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.
Time frame: approximately 12 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Overall Pain | 4.4 score on a scale | Standard Deviation 2.7 |
| Control Group | Overall Pain | 5.4 score on a scale | Standard Deviation 2.8 |
p-value: 0.2196Wilcoxon (Mann-Whitney)
Secondary
Pain at Rest
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.
Time frame: approximately 12 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain at Rest | 4.0 score on a scale | Standard Deviation 3 |
| Control Group | Pain at Rest | 5.0 score on a scale | Standard Deviation 3.2 |
p-value: 0.3057Wilcoxon (Mann-Whitney)
Secondary
Pain at Rest
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.
Time frame: baseline - arrival at the PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain at Rest | 2.1 score on a scale | Standard Deviation 3.6 |
| Control Group | Pain at Rest | 2.6 score on a scale | Standard Deviation 3.3 |
p-value: 0.3989Wilcoxon (Mann-Whitney)
Secondary
Pain at Rest
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.
Time frame: 30 minutes after arrival to PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain at Rest | 3.3 score on a scale | Standard Deviation 3.6 |
| Control Group | Pain at Rest | 5.1 score on a scale | Standard Deviation 3.6 |
p-value: 0.1029Wilcoxon (Mann-Whitney)
Secondary
Pain at Rest
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.
Time frame: post-operative day 1 at 1 am
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain at Rest | 4.0 score on a scale | Standard Deviation 3.1 |
| Control Group | Pain at Rest | 4.6 score on a scale | Standard Deviation 1.9 |
p-value: 0.3166Wilcoxon (Mann-Whitney)
Secondary
Pain at Rest
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.
Time frame: post-operative day 1 at 1 pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain at Rest | 4.0 score on a scale | Standard Deviation 2.3 |
| Control Group | Pain at Rest | 4.8 score on a scale | Standard Deviation 2.4 |
p-value: 0.4194Wilcoxon (Mann-Whitney)
Secondary
Pain With Coughing
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.
Time frame: approximately 12 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain With Coughing | 4.7 score on a scale | Standard Deviation 3.1 |
| Control Group | Pain With Coughing | 7.6 score on a scale | Standard Deviation 2.4 |
p-value: 0.0404Wilcoxon (Mann-Whitney)
Secondary
Pain With Coughing
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.
Time frame: post-operative day 1 at 1 am
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain With Coughing | 5.4 score on a scale | Standard Deviation 3.4 |
| Control Group | Pain With Coughing | 7.1 score on a scale | Standard Deviation 2.1 |
p-value: 0.2363Wilcoxon (Mann-Whitney)
Secondary
Pain With Coughing
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.
Time frame: 30 minutes after arrival to PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain With Coughing | 4.3 score on a scale | Standard Deviation 3.9 |
| Control Group | Pain With Coughing | 5.8 score on a scale | Standard Deviation 3.1 |
p-value: 0.3136Wilcoxon (Mann-Whitney)
Secondary
Pain With Coughing
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.
Time frame: baseline - arrival at the PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain With Coughing | 2.3 score on a scale | Standard Deviation 3.9 |
| Control Group | Pain With Coughing | 2.5 score on a scale | Standard Deviation 3.2 |
p-value: 0.5285Wilcoxon (Mann-Whitney)
Secondary
Pain With Coughing
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.
Time frame: post-operative day 1 at 1 pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain With Coughing | 5.4 score on a scale | Standard Deviation 2.7 |
| Control Group | Pain With Coughing | 5.8 score on a scale | Standard Deviation 3.1 |
p-value: 0.7073Wilcoxon (Mann-Whitney)
Secondary
Quality of Recovery
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.
Time frame: Day 15 post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Quality of Recovery | Able to look after personal toliet and hygiene | 9.2 score on a scale | Standard Deviation 2.3 |
| Treatment Group | Quality of Recovery | Feeling comfortable and in control | 7.1 score on a scale | Standard Deviation 2.5 |
| Treatment Group | Quality of Recovery | Been able to enjoy food | 6.2 score on a scale | Standard Deviation 3.7 |
| Treatment Group | Quality of Recovery | Having a feeling of general well-being | 7.5 score on a scale | Standard Deviation 2.2 |
| Treatment Group | Quality of Recovery | Able to communicate with family or friends | 9.6 score on a scale | Standard Deviation 1.1 |
| Treatment Group | Quality of Recovery | Moderate pain | 7.9 score on a scale | Standard Deviation 2.5 |
| Treatment Group | Quality of Recovery | Have had a good sleep | 7.1 score on a scale | Standard Deviation 1.9 |
| Treatment Group | Quality of Recovery | Severe pain | 9.4 score on a scale | Standard Deviation 1.8 |
| Treatment Group | Quality of Recovery | Getting support from hospital doctors and nurse | 8.8 score on a scale | Standard Deviation 3.1 |
| Treatment Group | Quality of Recovery | Nausea or vomiting | 8.6 score on a scale | Standard Deviation 2.3 |
| Treatment Group | Quality of Recovery | Feeling rested | 7.2 score on a scale | Standard Deviation 1.8 |
| Treatment Group | Quality of Recovery | Feeling worried or anxious | 7.7 score on a scale | Standard Deviation 3 |
| Treatment Group | Quality of Recovery | Able to return to work or usual home activities | 5.4 score on a scale | Standard Deviation 3.5 |
| Treatment Group | Quality of Recovery | Feeling sad or depressed | 8.4 score on a scale | Standard Deviation 2.6 |
| Treatment Group | Quality of Recovery | Able to breathe easily | 9.1 score on a scale | Standard Deviation 1.8 |
| Control Group | Quality of Recovery | Feeling sad or depressed | 7.8 score on a scale | Standard Deviation 3.1 |
| Control Group | Quality of Recovery | Able to breathe easily | 8.7 score on a scale | Standard Deviation 1.8 |
| Control Group | Quality of Recovery | Been able to enjoy food | 5.4 score on a scale | Standard Deviation 2.9 |
| Control Group | Quality of Recovery | Feeling rested | 6.0 score on a scale | Standard Deviation 2.2 |
| Control Group | Quality of Recovery | Have had a good sleep | 6.6 score on a scale | Standard Deviation 2.4 |
| Control Group | Quality of Recovery | Able to look after personal toliet and hygiene | 8.8 score on a scale | Standard Deviation 2.3 |
| Control Group | Quality of Recovery | Able to communicate with family or friends | 9.3 score on a scale | Standard Deviation 1.4 |
| Control Group | Quality of Recovery | Getting support from hospital doctors and nurse | 9.5 score on a scale | Standard Deviation 0.7 |
| Control Group | Quality of Recovery | Able to return to work or usual home activities | 4.9 score on a scale | Standard Deviation 3.2 |
| Control Group | Quality of Recovery | Feeling comfortable and in control | 6.7 score on a scale | Standard Deviation 2.7 |
| Control Group | Quality of Recovery | Having a feeling of general well-being | 6.7 score on a scale | Standard Deviation 2.2 |
| Control Group | Quality of Recovery | Moderate pain | 6.6 score on a scale | Standard Deviation 2.7 |
| Control Group | Quality of Recovery | Severe pain | 8.8 score on a scale | Standard Deviation 2.2 |
| Control Group | Quality of Recovery | Nausea or vomiting | 8.2 score on a scale | Standard Deviation 2.6 |
| Control Group | Quality of Recovery | Feeling worried or anxious | 7.6 score on a scale | Standard Deviation 2.5 |
Secondary
Total Opioid Consumption
Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.
Time frame: up to 24 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Total Opioid Consumption | 7.4 mg | Standard Deviation 5.4 |
| Control Group | Total Opioid Consumption | 7.9 mg | Standard Deviation 6.4 |
p-value: 0.8927Wilcoxon (Mann-Whitney)