Perioperative Lidocaine and Ketamine in Abdominal Surgery

NCT04084548 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: FLA 18-088
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Multimodal analgesia; Lidocaine; Ketamine; Abdominal surgery

Outcome Measures

Primary Outcomes (2)

• Pain scores

  Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.

  First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).

• Total opioid consumption

  Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.

  First postoperative 48 hours

Secondary Outcomes (2)

• Overall benefit of analgesia score (OBAS)

  First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).

• Quality of recovery (QoR-15) score

  First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).

Other Outcomes (3)

• Time to first opioid administration

  The amount of time from PACU admission to PACU discharge

• Postoperative hospital length of stay

  The number of days from hospital admission to hospital discharge

• Nausea or vomiting

  First postoperative 48 hours

Study Arms (4)

Lidocaine and placebo

EXPERIMENTAL

Lidocaine and placebo

Drug: Lidocaine

Ketamine and placebo

EXPERIMENTAL

Ketamine and placebo

Drug: Ketamine

Lidocaine and ketamine

EXPERIMENTAL

Lidocaine and ketamine

Drug: Lidocaine and ketamine

Placebo and placebo

PLACEBO COMPARATOR

Placebo and placebo

Drug: Placebo

Interventions

Lidocaine and ketamine DRUG

Perioperative lidocaine and ketamine infusion (see below for dosages and timings)

Lidocaine and ketamine

Lidocaine DRUG

Perioperative lidocaine infusion (1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)

Lidocaine and placebo

Ketamine DRUG

Perioperative ketamine infusion (0.5 mg/kg bolus followed by an infusion of 0.3 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)

Ketamine and placebo

Placebo DRUG

Perioperative placebo infusion (normal saline)

Placebo and placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (6)

• 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.

  PMID: 23011561 BACKGROUND

• 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.

  PMID: 29864216 BACKGROUND

• 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.

  PMID: 15621365 BACKGROUND

• 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.

  PMID: 29390443 BACKGROUND

• 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.

  PMID: 29384867 BACKGROUND

• 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.

  PMID: 23044681 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Steven Minear, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy-prepared medications.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: September 10, 2019
• Study Start: October 15, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)