Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery

October 20, 2023 updated by: Mahidol University

The Effect of Intraoperative Lidocaine Infusion and Intraoperative Lidocaine Combined With Ketamine Infusion on Opioid Consumption After Laparoscopic Bariatric Surgery: A Randomized Controlled Trial

The most effective long-term treatment for obesity is bariatric surgery, however, postoperative pain control is challenging in these group of population. Opioid-sparing technique with multimodal analgesia is recommended but the evidence supported is still limited. Multimodal analgesia, particularly lidocaine and ketamine, has been used effectively in various type of surgery. However, the evidence supported their use in obese patients undergoing bariatric surgery is limited.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of obesity and associated diseases have been increasing in recent decades. From 1980 to 2013, the number of adults with BMI more than 25 kg/m2 increased from 28.8% to 36.9% in men, and from 29.8% to 38% in women. According to World Health Organization (WHO), the prevalence of overweight among adults in Thailand in 2016 was 32.6%, markedly increased from 2011 which was 23.9%. To date, the most effective long-term treatment for obesity is bariatric surgery because of significantly reducing body fat, the development of new obesity-related conditions, and overall mortality. However, postoperative complications, particularly respiratory complication, are concerned because obesity is associated with respiratory compromise and sleep-disordered breathing. The 2016 guideline for perioperative care in bariatric surgery developed by enhanced recovery after surgery (ERAS) society state that, regarding to current evidence, there is no specific anesthetic agents or techniques for bariatric surgery, however, multimodal analgesia should be used to reduce opioid consumption and opioid-related complications such as respiratory depression, postoperative nausea and vomiting and ileus. Moreover, several studies supported opioid-sparing technique to avoid respiratory complications.

Intravenous lidocaine is widely used to reduce postoperative pain and to reduce perioperative opioid as a multimodal analgesia. From Cochrane review, perioperative lidocaine can decrease pain at rest, postoperative ileus and postoperative nausea and vomiting in elective and urgent surgery. Few trials in obese patients underwent laparoscopic bariatric surgery found that lidocaine infusion can decrease opioid consumption. However, the supported evidence is still limit. Ketamine has been used for postoperative analgesia as well, as an effective adjunct to decrease opioid consumption in various types of surgery, including open bariatric surgery. Moreover, the recent retrospective study (Tovikkai P, in press) found that there was a positive interaction between intraoperative lidocaine infusion and ketamine for decreasing opioid consumption in obese patients underwent laparoscopic bariatric surgery. However, the benefit of lidocaine and ketamine for postoperative pain in obese patients underwent laparoscopic bariatric surgery is still debated.

Therefore, we designed this study to examine the effect of intraoperative lidocaine infusion and intraoperative lidocaine infusion combined with intraoperative low-dose ketamine infusion on opioid consumption in obese patients undergoing laparoscopic bariatric surgery.

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults patients age older than 18 years.
  2. Body mass index more than 30 kg/m2.
  3. Scheduled for laparoscopic bariatric surgery, including laparoscopic sleeve gastrectomy, robotic-assisted laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass surgery or robotic-assisted laparoscopic gastric bypass.

Exclusion Criteria:

  1. Patient refusal.
  2. Inability to communicate or read in Thai language.
  3. Allergic to lidocaine or ketamine.
  4. History of opioid use within 2 weeks before surgery
  5. Cardiovascular disorder, including high grade atrioventricular block (second degree or third degree), history of coronary artery disease, poor controlled hypertension.
  6. History of stroke, intracranial hemorrhage or intracranial mass
  7. Cognitive impairment
  8. Schizophrenia or history of antipsychotic drugs
  9. Pregnant or breast-feeding patients
  10. Conversion to open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine and Ketamine
Participants in this arm will receive intra-operative lidocaine and ketamine infusion as adjunctive drugs for pain control. All medication is dosed based on calculated lean body weight (LBW) by Janmahasatian formula.
Drug: Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Other Names:
  • Li
Drug: Ketamine
Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Other Names:
  • Ke
Active Comparator: Lidocaine
Participants in this arm will receive only intra-operative ketamine infusion as adjunctive drugs for pain control. All medication is dosed based on calculated lean body weight (LBW) by Janmahasatian formula.
Drug: Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Other Names:
  • Li
Drug: Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Other Names:
  • Normal Saline
Placebo Comparator: Placebo
Participants in this arm will receive normal saline, same volume as lidocaine and ketamine.
Drug: Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 24-hour
Opioid consumption at 24 hr post-operation using Morphine Milligram equivalents(MME)
24-hour
Score of post-extubation cough
Time Frame: up to 24 hours (at extubation period after surgery finished)
post-extubation cough graded by care giver using modified Minogue scales, which defined grade1 as no coughing or muscular stiffness, grade 2 as coughing once or twice, or transient cough response to removal of tracheal tube that resolved with extubation, grade 3 as ≤ 3 coughs lasting 1-2 seconds, or total duration of coughing last ≤ 5 seconds and grade 4 as ≥ 4 coughs with each lasting > 2 seconds, total duration of coughing last > 5 seconds.
up to 24 hours (at extubation period after surgery finished)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: intraoperative (since the incision started until finished the last suture)
time since incision started until the last suture done recorded in minutes.
intraoperative (since the incision started until finished the last suture)
anesthetic time
Time Frame: intraoperative (since anesthetic started until patient out of the operating room)
time since anesthetic started until finished and patient out of room recorded in minutes.
intraoperative (since anesthetic started until patient out of the operating room)
the length of hospital stay
Time Frame: until 30-day postoperation
time since admission until discharge recorded in hours.
until 30-day postoperation
numbers of participants with postoperative complications
Time Frame: until 30-day postoperation
cardiac arrhythmia, myocardial infarction, respiratory compromised, reintubation, readmission.
until 30-day postoperation
Score of sore throat
Time Frame: assess at 24-hour post-operation
sore throat score grading by self-assessment score, which defined grade 0 as no sore throat, grade 1 as minimal sore throat, grade 2 as moderate sore throat and grade 3 as severe sore throat.
assess at 24-hour post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Parichat Tovikkai, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 610/2563(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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