Lidocaine + Ketamine for Postoperative Pain

Overseen By Steven Minear, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Cleveland Clinic

Must not be taking: Gabapentin, Magnesium, Nitrous oxide, others

Disqualifiers: Pregnancy, Morbid obesity, Cardiac failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration (2+ hours)

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Steven Minear, MD

Principal Investigator

Cleveland Clinic Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You had surgery with general anesthesia that lasted 2 hours or more.

Elective inpatient open or laparoscopic abdominal surgery

Exclusion Criteria

Pregnancy or breastfeeding

You are scheduled to need a breathing machine after surgery.

You are planning to have regional anesthesia or pain relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive perioperative infusions of lidocaine and/or ketamine during abdominal surgery

Surgery duration (2+ hours)

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for opioid consumption, pain scores, and other outcomes for 48 hours post-surgery

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Lidocaine

Trial Overview 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.

How Is the Trial Designed?

Group I: Lidocaine and placebo Experimental Treatment 1 Intervention

Lidocaine and placebo

Group II: Lidocaine and ketamine Experimental Treatment 1 Intervention

Lidocaine and ketamine

Group III: Ketamine and placebo Experimental Treatment 1 Intervention

Ketamine and placebo

Group IV: Placebo and placebo Placebo Group 1 Intervention

Placebo and placebo

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+