Clinical trial NCT04084548: Perioperative Lidocaine and Ketamine in Abdominal Surgery
Official title: Lidocaine and Ketamine in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Multimodal analgesia
Lidocaine
Ketamine
Abdominal surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
Primary purpose: TREATMENT

Brief summary: The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery.

Detailed description: The investigators propose a prospective, randomized, double-blind, placebo-controlled clinical trial (RCT) with a factorial design. Adults 18 to 80 years old having elective inpatient open or laparoscopic abdominal surgery with general anesthesia lasting 2 hours or longer will be included in this study.

Eligibility criteria: Inclusion Criteria:

* Adults 18 to 80 years old
* Elective inpatient open or laparoscopic abdominal surgery
* General anesthesia lasting 2 hours or longer.

Exclusion Criteria:

* 1. Planned postoperative mechanical ventilation
* 2. Planned regional anesthesia/analgesia
* 3. Perioperative gabapentin, magnesium, or nitrous oxide use
* 4. Pregnancy or breastfeeding
* 5. Morbid obesity (BMI ≥ 35 kg/m2)
* 6. American Society of Anesthesiologists (ASA) physical status IV-V
* 7. Allergy to study medications
* 8. Contraindication to lidocaine (severe cardiac arrhythmia)
* 9. Contraindication to ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of monoamine oxidase inhibitors)
* 10. Chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for \> 3 months)
* 11. Significant preoperative hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels \> 5 times normal) or planned liver transplantation
* 12. Preoperative cardiac failure (left ventricular ejection fraction ≤ 40%)
* 13. Unable to communicate or comprehend study instructions

Primary outcomes:
measure: Pain scores
timeFrame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
measure: Total opioid consumption
timeFrame: First postoperative 48 hours
Secondary outcomes:
measure: Overall benefit of analgesia score (OBAS)
timeFrame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
measure: Quality of recovery (QoR-15) score
timeFrame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Other outcomes:
measure: Time to first opioid administration
timeFrame: The amount of time from PACU admission to PACU discharge
measure: Postoperative hospital length of stay
timeFrame: The number of days from hospital admission to hospital discharge
measure: Nausea or vomiting
timeFrame: First postoperative 48 hours
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Steven Minear, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grady MV, Mascha E, Sessler DI, Kurz A. The effect of perioperative intravenous lidocaine and ketamine on recovery after abdominal hysterectomy. Anesth Analg. 2012 Nov;115(5):1078-84. doi: 10.1213/ANE.0b013e3182662e01. Epub 2012 Sep 25.
citation: Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
citation: Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
citation: Ye F, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9147. doi: 10.1097/MD.0000000000009147.
citation: Zhao JB, Li YL, Wang YM, Teng JL, Xia DY, Zhao JS, Li FL. Intravenous lidocaine infusion for pain control after laparoscopic cholecystectomy: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(5):e9771. doi: 10.1097/MD.0000000000009771.
citation: Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.