Perioperative Lidocaine and Ketamine in Abdominal Surgery
NCT04084548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2025-05-21
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.
Conditions
- Postoperative Pain
Interventions
- DRUG
-
Lidocaine and ketamine
Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
- 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)
- DRUG
-
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)
- DRUG
-
Perioperative placebo infusion (normal saline)
Sponsors & Collaborators
-
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Steven Minear, MD · Cleveland Clinic Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-10-15
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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