NCT04084548

Perioperative Lidocaine and Ketamine in Abdominal Surgery

Lidocaine and Ketamine in Abdominal Surgery

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
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	Ketamine	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	Placebo	Perioperative placebo infusion (normal saline)

Timeline

• Start date: 2019-10-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-09-10
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study