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Trial record 1 of 1 for:    29864216 [PUBMED-IDS]
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Perioperative Lidocaine and Ketamine in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04084548
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Lidocaine and ketamine Drug: Lidocaine Drug: Ketamine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacy-prepared medications.
Primary Purpose: Treatment
Official Title: Lidocaine and Ketamine in Abdominal Surgery
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lidocaine and placebo
Lidocaine and placebo
Drug: Lidocaine
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)

Experimental: Ketamine and placebo
Ketamine and placebo
Drug: Ketamine
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)

Experimental: Lidocaine and ketamine
Lidocaine and ketamine
Drug: Lidocaine and ketamine
Perioperative lidocaine and ketamine infusion (see below for dosages and timings)

Placebo Comparator: Placebo and placebo
Placebo and placebo
Drug: Placebo
Perioperative placebo infusion (normal saline)




Primary Outcome Measures :
  1. Pain scores [ Time Frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings). ]
    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.

  2. Total opioid consumption [ Time Frame: First postoperative 48 hours ]
    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.


Secondary Outcome Measures :
  1. Overall benefit of analgesia score (OBAS) [ Time Frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings). ]
    Measures 7 different items, i.e. current pain, vomiting, itching, sweating, freezing, dizziness, and patient satisfaction related to pain management. Each item is scored from 0 to 4, with the total OBAS score ranging from 0 to 28. The lower the total OBAS score, the higher the benefit of analgesia.

  2. Quality of recovery (QoR-15) score [ Time Frame: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings). ]
    Measures 15 different items, i.e. ability to breathe easily, enjoy food, feel rested, have a good sleep, look after personal toilet and hygiene unaided, communicate with family or friends, getting support from hospital doctors and nurses, return to work or usual home activities, feel comfortable and in control, have a feeling of general well-being, as well as the presence of moderate pain, severe pain, nausea or vomiting, feeling worried or anxious, and feeling sad or depressed. Each item is scored from 0 to 10, with a total QoR-15 score ranging from 0 to 150. The higher the QoR-15 score, the better the quality of recovery in the postoperative period.


Other Outcome Measures:
  1. Time to first opioid administration [ Time Frame: The amount of time from PACU admission to PACU discharge ]
    Measured in minutes

  2. Postoperative hospital length of stay [ Time Frame: The number of days from hospital admission to hospital discharge ]
    Measured in days

  3. Nausea or vomiting [ Time Frame: First postoperative 48 hours ]
    Measured as dichotomous outcome (yes/no)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084548


Contacts
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Contact: Rebecca Y Wong, MBBS, MPH 954-789-8933 wongr3@ccf.org
Contact: Santiago Luis, MD 954-495-5338 luiss@ccf.org

Locations
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United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Rebecca Y Wong, MBBS, MPH    954-789-8933    wongr3@ccf.org   
Principal Investigator: Rebecca Y Wong, MBBS, MPH         
Sub-Investigator: Santiago Luis, MD         
Sub-Investigator: Daniel I Sessler, MD         
Sub-Investigator: Emanuele Lo Menzo, MD, PhD         
Sub-Investigator: Edward J Mascha, PhD         
Sub-Investigator: Chen Liang, MS         
Sub-Investigator: Allen Collins, AAB         
Sub-Investigator: Jeffrey Jacobs, MD         
Sub-Investigator: Tatiana Jamroz, MD         
Sub-Investigator: Ricardo Plata Aguilar, MD         
Sub-Investigator: Gerges Azer, MD         
Sub-Investigator: Rene Aleman, MD         
Sub-Investigator: Joel Frieder, MD         
Sub-Investigator: Estelle Swanson, RN         
Sub-Investigator: Kindlee Lindsay, ARNP         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Rebecca Y Wong, MBBS, MPH Cleveland Clinic Florida
  Study Documents (Full-Text)

Documents provided by The Cleveland Clinic:
Informed Consent Form  [PDF] January 17, 2019


Publications:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04084548     History of Changes
Other Study ID Numbers: FLA 18-088
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Multimodal analgesia
Lidocaine
Ketamine
Abdominal surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents