Perioperative Lidocaine and Ketamine in Abdominal Surgery

May 20, 2025 updated by: The Cleveland Clinic

Lidocaine and Ketamine in Abdominal Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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
Drug: Lidocaine and ketamine
Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
Placebo Comparator: Placebo and placebo
Drug: Placebo
Perioperative placebo infusion (normal saline)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
First postoperative 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first opioid administration
Time Frame: The amount of time from PACU admission to PACU discharge
Measured in minutes
The amount of time from PACU admission to PACU discharge
Postoperative hospital length of stay
Time Frame: The number of days from hospital admission to hospital discharge
Measured in days
The number of days from hospital admission to hospital discharge
Nausea or vomiting
Time Frame: First postoperative 48 hours
Measured as dichotomous outcome (yes/no)
First postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Minear, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FLA 18-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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