Perioperative Lidocaine and Ketamine in Abdominal Surgery

Postoperative Pain Clinical Trial

Official title:

Lidocaine and Ketamine in Abdominal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04084548
• Other study ID #: FLA 18-088
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 15, 2019
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine and ketamine
Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
• 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)
• 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)
• Placebo
Perioperative placebo infusion (normal saline)

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (6)

Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036. — View Citation

Grady MV, Mascha E, Sessler DI, Kurz A. The effect of perioperative intravenous lidocaine and ketamine on recovery after abdominal hysterectomy. Anesth Analg. 2012 Nov;115(5):1078-84. doi: 10.1213/ANE.0b013e3182662e01. Epub 2012 Sep 25. — View Citation

Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8. Erratum In: Dis Colon Rectum. 2013 Feb;52(2):271. — View Citation

Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3. — View Citation

Ye F, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9147. doi: 10.1097/MD.0000000000009147. — View Citation

Zhao JB, Li YL, Wang YM, Teng JL, Xia DY, Zhao JS, Li FL. Intravenous lidocaine infusion for pain control after laparoscopic cholecystectomy: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(5):e9771. doi: 10.1097/MD.0000000000009771. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first opioid administration	Measured in minutes	The amount of time from PACU admission to PACU discharge
Other	Postoperative hospital length of stay	Measured in days	The number of days from hospital admission to hospital discharge
Other	Nausea or vomiting	Measured as dichotomous outcome (yes/no)	First postoperative 48 hours
Primary	Pain scores	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.	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Primary	Total opioid consumption	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.	First postoperative 48 hours
Secondary	Overall benefit of analgesia score (OBAS)	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.	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Secondary	Quality of recovery (QoR-15) score	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.	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).