Phase 4
N=48
Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Pancreatectomy
Bottom Line
View on ClinicalTrials.gov: NCT02623803 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Overall Pain in Postoperative Period — 1.6; 2.7 score on a scale — p=0.1459
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); Placebo D5W (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Pain in Postoperative Period |
1.6; 2.7 | 0.1459 |
| PRIMARY Opioid Consumption |
3.9; 6.7 | 0.2050 |
| SECONDARY Pain at Rest |
4.0; 4.8 | 0.4194 |
| SECONDARY Pain With Coughing |
5.4; 5.8 | 0.7073 |
| SECONDARY Overall Pain |
4.8; 4.8 | 0.9171 |
| SECONDARY Pain at Rest |
4.0; 4.8 | 0.4194 |
| SECONDARY Pain With Coughing |
5.4; 5.8 | 0.7073 |
| SECONDARY Overall Pain |
4.8; 4.8 | 0.9171 |
| SECONDARY Pain at Rest |
4.0; 4.8 | 0.4194 |
| SECONDARY Pain With Coughing |
5.4; 5.8 | 0.7073 |
| SECONDARY Overall Pain |
4.8; 4.8 | 0.9171 |
| SECONDARY Pain at Rest |
4.0; 4.8 | 0.4194 |
| SECONDARY Pain With Coughing |
5.4; 5.8 | 0.7073 |
| SECONDARY Overall Pain |
4.8; 4.8 | 0.9171 |
| SECONDARY Pain at Rest |
4.0; 4.8 | 0.4194 |
| SECONDARY Pain With Coughing |
5.4; 5.8 | 0.7073 |
| SECONDARY Length of Time to First Flatus |
3.9; 2.7 | 0.5107 |
| SECONDARY Length of Time to First Bowel Movement |
5.8; 5.2 | 0.8339 |
| SECONDARY Total Opioid Consumption |
7.4; 7.9 | 0.8927 |
| SECONDARY Quality of Recovery |
9.1; 8.7; 6.2; 5.4; 7.2; 6.0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02623803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.