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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 weeks
Treatment ~ Varies
Follow Up ~first postoperative 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and first postoperative 48 hours for reporting.

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
1,052 Previous Clinical Trials
1,370,694 Total Patients Enrolled
9 Trials studying Postoperative Pain
3,021 Patients Enrolled for Postoperative Pain
Steven Minear, MDPrincipal InvestigatorCleveland Clinic Florida

Media Library

Lidocaine and ketamine Clinical Trial Eligibility Overview. Trial Name: NCT04084548 — Phase 3
Postoperative Pain Research Study Groups: Lidocaine and placebo, Lidocaine and ketamine, Placebo and placebo, Ketamine and placebo
Postoperative Pain Clinical Trial 2023: Lidocaine and ketamine Highlights & Side Effects. Trial Name: NCT04084548 — Phase 3
Lidocaine and ketamine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04084548 — Phase 3
~0 spots leftby Dec 2024
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