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NCT Number: NCT04836819

Analgesia Management in Bariatric Surgery

Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.

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Key information

Conditions

Morbid Obesity Bariatric Surgery Candidate Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Postoperative Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55270, Turkey (Türkiye)

About this study

Patients will be divided into three groups.

Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.

Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index>35 kg/m2
  • The American Society of Anaesthesiologists (ASA) physical status class II III
  • Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion criteria

  • refusal to participate
  • allergy to the study drugs
  • chronic kidney disease (creatinine>150 μmol/L)
  • mental illness
  • liver, respiratory or oncological disease,
  • cardiac dysfunction (ejection fraction <40%),
  • uncontrolled hypertension,
  • preoperative analgesic use,
  • chronic pain,
  • history of alcohol or drug addiction

Treatment and study plan

Lidocain

Drug

IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.

ketamine

Drug

IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.

Dexmedetomidine

Drug

IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.

Primary outcomes

  1. Postoperative pain: VAS scores at rest and movement

    Time frame: Up to 15 days after the surgery.

    Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable).

Secondary outcomes

  1. Postoperative Rescue Analgesic Requirement

    Time frame: Up to three days after surgery

    After the end of surgery 25-50 mg meperidine (maximum dose 200 mg) will be administered i.m. as rescue analgesia when requested by the patient and if VAS>4. the Rescue analgesic dosage will be recorded.

  2. Postoperative nausea, retching and vomiting

    Time frame: Up to 3 days after surgery.

    The number of patients who has complained of nausea, retching and vomiting will be recorded.

  3. Time to first mobilization

    Time frame: Up to 24 hours after surgery.

    The patients first mobilization time after the operation will be recorded.

  4. Time to discharge

    Time frame: Trough hospital stay, an average of 1 week.

    The length of hospital stay will be recorded.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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