Your session is about to expire
← Back to Search
Lidocaine + Ketamine for Postoperative Pain
Phase 3
Waitlist Available
Led By Steven Minear, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first postoperative 48 hours (measured at the end of the pacu stay as well as on the 1st and 2nd postoperative mornings).
Awards & highlights
Pivotal Trial
Summary
This trial will test if lidocaine and/or ketamine reduces pain and need for opioids after surgery.
Who is the study for?
Adults aged 18-80 undergoing elective inpatient abdominal surgery with general anesthesia lasting over 2 hours can join. Excluded are pregnant or breastfeeding individuals, those needing post-op ventilation, using certain drugs like gabapentin, obese patients (BMI ≥35), people with severe heart failure or communication issues, and those allergic to the study meds.
What is being tested?
The trial is testing if lidocaine and/or ketamine given during surgery can reduce opioid use and pain after abdominal operations. Patients will receive either both drugs, just one of them, or a placebo in a randomized manner to compare their effects on postoperative recovery.
What are the potential side effects?
Possible side effects include reactions specific to lidocaine such as cardiac arrhythmias for at-risk individuals and ketamine-related issues like psychiatric disturbances or increased blood pressure in susceptible patients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first postoperative 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first postoperative 48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Total opioid consumption
Secondary study objectives
Overall benefit of analgesia score (OBAS)
Quality of recovery (QoR-15) score
Other study objectives
Nausea or vomiting
Postoperative hospital length of stay
Time to first opioid administration
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lidocaine and placeboExperimental Treatment1 Intervention
Lidocaine and placebo
Group II: Lidocaine and ketamineExperimental Treatment1 Intervention
Lidocaine and ketamine
Group III: Ketamine and placeboExperimental Treatment1 Intervention
Ketamine and placebo
Group IV: Placebo and placeboPlacebo Group1 Intervention
Placebo and placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine and ketamine
2023
Completed Phase 1
~50
Ketamine
2011
Completed Phase 4
~1120
Lidocaine
2011
Completed Phase 4
~1370
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,056 Previous Clinical Trials
1,371,197 Total Patients Enrolled
9 Trials studying Postoperative Pain
3,021 Patients Enrolled for Postoperative Pain
Steven Minear, MDPrincipal InvestigatorCleveland Clinic Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are scheduled to need a breathing machine after surgery.You are planning to have regional anesthesia or pain relief.You have used gabapentin, magnesium, or nitrous oxide around the time of your surgery.You are extremely overweight with a body mass index (BMI) of 35 or higher.You have a heart condition where your heart doesn't pump blood well.You are between 18 and 80 years old.You had surgery with general anesthesia that lasted 2 hours or more.You have a very serious health condition according to the American Society of Anesthesiologists.You are allergic to the medications being used in the study.You cannot have lidocaine if you have a serious heart rhythm problem.You have a condition or are taking certain medications that make it unsafe for you to receive ketamine.You have been taking a high amount of opioid pain medication for a long time before surgery.Your liver is not working properly, or you are planning to have a liver transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Lidocaine and placebo
- Group 2: Lidocaine and ketamine
- Group 3: Placebo and placebo
- Group 4: Ketamine and placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.