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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

420

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

The Cleveland Clinic

Investigators

  • 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)

October 15, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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