Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Lidocaine Hydrochloride (DRUG)
    lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
  • Ketamine (DRUG)
    Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
  • Placebo (DRUG)
    Normal saline will be given with the same rate of lidocaine or ketamine.

Condition or Disease

  • Laparoscopic Bariatric Surgery

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 87 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2021 ACTUAL
    Primary Completion: Jun 30, 2023 ESTIMATED
    Completion Date: Jul 30, 2023 ESTIMATED
    Study First Posted: Aug 24, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 08, 2022

    Sponsors / Collaborators

    Lead Sponsor: Mahidol University
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    • 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.

    • Participants in this arm will receive normal saline, same volume as lidocaine and ketamine.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Opioid consumption at 24 hr post-operation using Morphine Milligram equivalents(MME)

    • 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.

    Secondary Outcomes

    • time since incision started until the last suture done recorded in minutes.

    • time since anesthetic started until finished and patient out of room recorded in minutes.

    • time since admission until discharge recorded in hours.

    • cardiac arrhythmia, myocardial infarction, respiratory compromised, reintubation, readmission.

    • 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.

    More Details

    NCT Number: NCT04524130
    Other IDs: 610/2563(IRB3)
    Study URL: https://clinicaltrials.gov/study/NCT04524130
    Last updated: Sep 29, 2023