Perioperative Lidocaine and Ketamine in Abdominal Surgery

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04084548

Collaborator

(none)

420

Enrollment

Location

Arms

37.6

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Lidocaine and ketamine Drug: Lidocaine Drug: Ketamine Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Pharmacy-prepared medications.

Primary Purpose:

Treatment

Official Title:

Lidocaine and Ketamine in Abdominal Surgery

Actual Study Start Date :

Oct 15, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine and placebo Lidocaine and placebo	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)
Experimental: Ketamine and placebo Ketamine and placebo	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)
Experimental: Lidocaine and ketamine Lidocaine and ketamine	Drug: Lidocaine and ketamine Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
Placebo Comparator: Placebo and placebo Placebo and placebo	Drug: Placebo Perioperative placebo infusion (normal saline)

Outcome Measures

Primary Outcome Measures

Pain scores [First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).]
Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Total opioid consumption [First postoperative 48 hours]
Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.

Secondary Outcome Measures

Overall benefit of analgesia score (OBAS) [First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).]
Measures 7 different items, i.e. current pain, vomiting, itching, sweating, freezing, dizziness, and patient satisfaction related to pain management. Each item is scored from 0 to 4, with the total OBAS score ranging from 0 to 28. The lower the total OBAS score, the higher the benefit of analgesia.
Quality of recovery (QoR-15) score [First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).]
Measures 15 different items, i.e. ability to breathe easily, enjoy food, feel rested, have a good sleep, look after personal toilet and hygiene unaided, communicate with family or friends, getting support from hospital doctors and nurses, return to work or usual home activities, feel comfortable and in control, have a feeling of general well-being, as well as the presence of moderate pain, severe pain, nausea or vomiting, feeling worried or anxious, and feeling sad or depressed. Each item is scored from 0 to 10, with a total QoR-15 score ranging from 0 to 150. The higher the QoR-15 score, the better the quality of recovery in the postoperative period.

Other Outcome Measures

Time to first opioid administration [The amount of time from PACU admission to PACU discharge]
Measured in minutes
Postoperative hospital length of stay [The number of days from hospital admission to hospital discharge]
Measured in days
Nausea or vomiting [First postoperative 48 hours]
Measured as dichotomous outcome (yes/no)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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