Perioperative Lidocaine and Ketamine in Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lidocaine and Ketamine in Abdominal Surgery

NCT00721110

Abdominal Hysterectomy (& Wertheim)

TERMINATED NA

Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

NCT01439399

Postoperative Pain

COMPLETED NA

Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

NCT06725485

Postoperative Pain Management

COMPLETED PHASE4

Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain

NCT02455609

Therapy Pain Management

UNKNOWN PHASE2/PHASE3

Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection

NCT00822133

Postoperative Pain

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Pharmacy-prepared medications.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine and placebo

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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)

Ketamine and placebo

Group Type EXPERIMENTAL

Ketamine

Intervention Type 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)

Lidocaine and ketamine

Group Type EXPERIMENTAL

Lidocaine and ketamine

Intervention Type DRUG

Perioperative lidocaine and ketamine infusion (see below for dosages and timings)

Placebo and placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Perioperative placebo infusion (normal saline)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine and ketamine

Perioperative lidocaine and ketamine infusion (see below for dosages and timings)

Intervention Type 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)

Intervention Type 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)

Intervention Type DRUG

Placebo

Perioperative placebo infusion (normal saline)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults 18 to 80 years old
* Elective inpatient open or laparoscopic abdominal surgery
* General anesthesia lasting 2 hours or longer.

Exclusion Criteria

* 1\. Planned postoperative mechanical ventilation
* 2\. Planned regional anesthesia/analgesia
* 3\. Perioperative gabapentin, magnesium, or nitrous oxide use
* 4\. Pregnancy or breastfeeding
* 5\. Morbid obesity (BMI ≥ 35 kg/m2)
* 6\. American Society of Anesthesiologists (ASA) physical status IV-V
* 7\. Allergy to study medications
* 8\. Contraindication to lidocaine (severe cardiac arrhythmia)
* 9\. Contraindication to ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of monoamine oxidase inhibitors)
* 10\. Chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for \> 3 months)
* 11\. Significant preoperative hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels \> 5 times normal) or planned liver transplantation
* 12\. Preoperative cardiac failure (left ventricular ejection fraction ≤ 40%)
* 13\. Unable to communicate or comprehend study instructions

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes