A Study of Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Overview

About this study

The purpose of this study is to evaluate if a lidocaine infusion during surgery will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)
  • Advanced 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
    • Stokes-Adams syndrome
    • Left bundle branch block
    • Bifascicular block
    • Not excluding patients with the following conditions unless clinical circumstances dictate
      • Atrial fibrillation or atrial flutter
      • Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
  • On anti-arrhythmic therapy i.e.
    • Digoxin
    • Amiodarone
    • Flecainide
    • Lidocaine
    • Sotalol
    • Etc
    • Not excluding patients on beta blockers i.e. metoprolol, atenolol, etc. unless clinical circumstance dictate
  • 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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Elird Bojaxhi, M.D.

Closed for enrollment

More information

Publications

  • Postoperative nausea and vomiting (PONV) is common but many episodes may be trivial or transient. The aim of the study was to develop a simple-to-use measure of the intensity and clinical impact of PONV. Read More on PubMed
  • The use of unidimensional pain scales such as the Numerical Rating Scale (NRS), Verbal Rating Scale (VRS), or Visual Analogue Scale (VAS) is recommended for assessment of pain intensity (PI). A literature review of studies specifically comparing the NRS, VRS, and/or VAS for unidimensional self-report of PI was performed as part of the work of the European Palliative Care Research Collaborative on pain assessment. Read More on PubMed
  • Continuous intravenous administration of lidocaine may decrease the duration of ileus and pain after abdominal surgery. Read More on PubMed
  • To characterize the beneficial effects of perioperative systemic lidocaine on length of hospital stay, gastrointestinal motility, and the inflammatory response after colorectal surgery. Read More on PubMed
  • Intravenous infusion of lidocaine decreases postoperative pain and speeds the return of bowel function. The authors therefore tested the hypothesis that perioperative lidocaine infusion facilitates acute rehabilitation protocol in patients undergoing laparoscopic colectomy. Read More on PubMed
  • A 40-item questionnaire (the QoR-40) had been previously developed to measure five dimensions of quality of recovery after anaesthesia and surgery. Each of the 40 items is rated on a scale of 1 to 5, with a maximum score of 200. In this study we compared patient self-administered with investigator-administered QoR-40. We studied 62 postoperative patients within 48 hours of their surgery. Agreement between the two methods was analysed using the intraclass correlation coefficient, bias and limits of agreement. There was strong correlation between the investigator-administered and patient self-administered QoR-40 scores, intraclass correlation coefficient 0.86 (95% CI: 0.77 to 0.92), P<0.001. The bias and limits of agreement were 3.1 and -22 to 28, respectively. There were 10 (16%) patient self-administered questionnaires that were not completed at first attempt. The time to complete the questionnaire when investigator-administered was 253 (16) s [mean, (SD)], and on first attempt for patients was 362 (19) s, P<0.001. The QoR-40 is as valid measure of postoperative recovery when administered with the assistance of an investigator as compared with the patient self-administered version. Investigator-administered measurement of the QoR-40 is a more efficient use of resources, as complete and more timely data are collected. Read More on PubMed
  • This randomized clinical trial compared the use of thoracic epidural anaesthesia-analgesia (TEA) with morphine patient-controlled analgesia (PCA) for pain relief after laparoscopic colectomy. Read More on PubMed
  • Goal-directed delivery of sedative and analgesic medications is recommended as standard care in intensive care units (ICUs) because of the impact these medications have on ventilator weaning and ICU length of stay, but few of the available sedation scales have been appropriately tested for reliability and validity. Read More on PubMed
  • Postoperative ileus has traditionally been accepted as a normal response to tissue injury. No data support any beneficial effect of ileus and indeed it may contribute to delayed recovery and prolonged hospital stay. Efforts should, therefore, be made to reduce such ileus. Read More on PubMed
  • Quality of recovery after anaesthesia is an important measure of the early postoperative health status of patients. We attempted to develop a valid, reliable and responsive measure of quality of recovery after anaesthesia and surgery. We studied 160 patients and asked them to rate postoperative recovery using three methods: a 100-mm visual analogue scale (VAS), a nine-item questionnaire and a 50-item questionnaire; the questionnaires were repeated later on the same day. From these results, we developed a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200). We found good convergent validity between QoR-40 and VAS (r = 0.68, P < 0.001). Construct validity was supported by a negative correlation with duration of hospital stay (rho = -0.24, P < 0.001) and a lower mean QoR-40 score in women (162 (SD 26)) compared with men (173 (17)) (P = 0.002). There was also good test-retest reliability (intra-class ri = 0.92, P < 0.001), internal consistency (Cronbach's alpha = 0.93, P < 0.001) and split-half coefficient (alpha = 0.83, P < 0.001). The standardized response mean, a measure of responsiveness, was 0.65. The QoR-40 was completed in less than 6.3 (4.9) min. We believe that the QoR-40 is a good objective measure of quality of recovery after anaesthesia and surgery. It would be a useful end-point in perioperative clinical studies. Read More on PubMed
  • The effects of continuous intravenous infusion of lidocaine on postoperative paralytic ileus in cholecystectomized patients was investigated in this double-blind study. An infusion of lidocaine (3 mg/min, n = 15) or an infusion of an equal volume of saline (n = 15) was started 30 min before induction of anesthesia and continued for 24 h after surgery. Postoperative colonic motility was evaluated by radiopaque markers and serial abdominal radiographs. A record was kept of the first passage of gas and feces. Results showed significantly earlier return of propulsive motility in the colon of lidocaine-treated patients. Radiopaque markers in the lidocaine group were propelled significantly earlier from the cecum/ascending colon to the transverse colon (P less than 0.05) and appeared significantly earlier in the descending colon (P less than 0.05) and the rectosigmoid colon (P less than 0.05) than in saline-treated patients. Despite the fact that the mean time for postoperative defecation occurred 17 h earlier in lidocaine-treated patients, differences between the groups were not statistically significant--a fact due, perhaps, to great individual variations in defecation habits. The time to first passage of gas, a variable representative of changes in anorectal or colonic tone rather than propagative motility, also did not differ significantly between the groups. No adverse reactions to lidocaine were reported. The results suggest that continuous intravenous infusion of lidocaine during the first postoperative day shortens the duration of paralytic ileus in the colon after abdominal surgery. Suppression of inhibitory gastrointestinal reflexes by reduction of postoperative peritoneal irritation is suggested as the mechanism of action. Read More on PubMed
  • Activation of afferent nerves in the area of surgery is a cause for surgical pain and stress. Intravenous (IV) lidocaine has been shown to inhibit postoperative pain. In the present double-blind study, the effects of a continuous IV infusion of lidocaine (2 mg/min) on the sympathoadrenal stress response to surgery were evaluated in 38 patients scheduled for elective cholecystectomy who were randomly assigned to two groups. In one group, lidocaine infusion was started 30 min before the operation and continued for 24 hr after surgery (n = 18). In the second group (n = 20), saline was infused. The increases in heart rate and blood pressure after tracheal intubation were not significantly different between the groups, but tachycardia and hypertension associated with extubation was prevented in patients given lidocaine. Differences in blood pressure and heart rate between the two groups were otherwise not significant intra- or postoperatively, nor were differences in blood glucose or plasma catecholamine concentrations during the first 24 hr after skin incision. Urinary catecholamine concentrations did not differ significantly in the two groups during the first postoperative day, but during the second postoperative day urinary output of epinephrine and norepinephrine were significantly less in the group of patients receiving lidocaine infusion. It was concluded that the IV infusion of lidocaine during and after major abdominal surgery suppresses extubation-induced hypertension and tachycardia but does not inhibit the general sympathetic response during the first postoperative day. However, lidocaine infusion reduces urinary output of catecholamines during the second postoperative day, suggesting a more rapid decline in the sympathoadrenal response postoperatively in the experimental group. Read More on PubMed
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CLS-20169967

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