Analgesia Management in Bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Morbid Obesity; Bariatric Surgery Candidate; Postoperative
• Intervention / Treatment: Drug: Lidocain; Drug: Ketamine; Drug: Dexmedetomidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atakum
    • Samsun, Atakum, Turkey, 55270
      • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group L; IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.	Drug: Lidocain; 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.
Active Comparator: Group K; IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.	Drug: Ketamine; 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.
Active Comparator: Group D; IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.	Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: VAS scores at rest and movement	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).	Up to 15 days after the surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Rescue Analgesic Requirement	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.	Up to three days after surgery
Postoperative nausea, retching and vomiting	The number of patients who has complained of nausea, retching and vomiting will be recorded.	Up to 3 days after surgery.
Time to first mobilization	The patients first mobilization time after the operation will be recorded.	Up to 24 hours after surgery.
Time to discharge	The length of hospital stay will be recorded.	Trough hospital stay, an average of 1 week.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: Ersin Koksal, Ondokuz Mayıs University

Publications and helpful links

General Publications

• Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
• Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
• Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
• Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
• Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Pain; Ketamine; Dexmedetomidine; Lidocaine; Postoperative; Morbid
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: SGPAM-DKL11

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