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Perioperative Lidocaine and Ketamine in Abdominal Surgery

Primary Purpose

Postoperative Pain

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lidocaine and ketamine

Lidocaine

Ketamine

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Multimodal analgesia, Lidocaine, Ketamine, Abdominal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cleveland Clinic FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine and placebo

Ketamine and placebo

Lidocaine and ketamine

Placebo and placebo

Arm Description

Lidocaine and placebo

Ketamine and placebo

Lidocaine and ketamine

Placebo and placebo

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Overall benefit of analgesia score (OBAS)

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.

Quality of recovery (QoR-15) score

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.

Full Information

NCT ID

NCT04084548

First Posted

February 5, 2019

Last Updated

February 13, 2023

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04084548

Brief Title

Perioperative Lidocaine and Ketamine in Abdominal Surgery

Official Title

Lidocaine and Ketamine in Abdominal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Multimodal analgesia, Lidocaine, Ketamine, Abdominal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Pharmacy-prepared medications.

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine and placebo

Arm Type

Experimental

Arm Description

Lidocaine and placebo

Arm Title

Ketamine and placebo

Arm Type

Experimental

Arm Description

Ketamine and placebo

Arm Title

Lidocaine and ketamine

Arm Type

Experimental

Arm Description

Lidocaine and ketamine

Arm Title

Placebo and placebo

Arm Type

Placebo Comparator

Arm Description

Placebo and placebo

Intervention Type

Drug

Intervention Name(s)

Lidocaine and ketamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Perioperative placebo infusion (normal saline)

Primary Outcome Measure Information:

Title

Pain scores

Description

Time Frame

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

Title

Total opioid consumption

Description

Time Frame

First postoperative 48 hours

Secondary Outcome Measure Information:

Title

Overall benefit of analgesia score (OBAS)

Description

Time Frame

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

Title

Quality of recovery (QoR-15) score

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Time to first opioid administration

Description

Measured in minutes

Time Frame

The amount of time from PACU admission to PACU discharge

Title

Postoperative hospital length of stay

Description

Measured in days

Time Frame

The number of days from hospital admission to hospital discharge

Title

Nausea or vomiting

Description

Measured as dichotomous outcome (yes/no)

Time Frame

First postoperative 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven Minear, MD

Phone

954-290-1569

minears@ccf.org

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca YS Wong, MBBS, MPH

Phone

954-789-8933

wongr3@ccf.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Minear, MD

Organizational Affiliation

Cleveland Clinic Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Minear, MD

Phone

954-290-1569

minears@ccf.org

First Name & Middle Initial & Last Name & Degree

Rebecca YS Wong, MBBS, MPH

Phone

954-789-8933

wongr3@ccf.org

First Name & Middle Initial & Last Name & Degree

Rebecca Y Wong, MBBS, MPH

First Name & Middle Initial & Last Name & Degree

Santiago Luis, MD

First Name & Middle Initial & Last Name & Degree

Daniel I Sessler, MD

First Name & Middle Initial & Last Name & Degree

Emanuele Lo Menzo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Edward J Mascha, PhD

First Name & Middle Initial & Last Name & Degree

Chen Liang, MS

First Name & Middle Initial & Last Name & Degree

Allen Collins, AAB

First Name & Middle Initial & Last Name & Degree

Jeffrey Jacobs, MD

First Name & Middle Initial & Last Name & Degree

Tatiana Jamroz, MD

First Name & Middle Initial & Last Name & Degree

Ricardo Plata Aguilar, MD

First Name & Middle Initial & Last Name & Degree

Gerges Azer, MD

First Name & Middle Initial & Last Name & Degree

Estelle Swanson, RN

First Name & Middle Initial & Last Name & Degree

Kindlee Lindsay, ARNP

First Name & Middle Initial & Last Name & Degree

Steven Minear, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23011561

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.

Results Reference

background

PubMed Identifier

29864216

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.

Results Reference

background

PubMed Identifier

15621365

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.

Results Reference

background

PubMed Identifier

29390443

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.

Results Reference

background

PubMed Identifier

29384867

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.

Results Reference

background

PubMed Identifier

23044681

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. Erratum In: Dis Colon Rectum. 2013 Feb;52(2):271.

Results Reference

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Perioperative Lidocaine and Ketamine in Abdominal Surgery

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