Clinical trial NCT04836819: Analgesia Management in Bariatric Surgery
Official title: Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Bariatric Surgery Candidate
Pain
Postoperative
Keywords: Dexmedetomidine
Ketamine
Lidocaine
Obesity
Morbid
Pain
Postoperative
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly classified into three groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain: VAS scores at rest and movement
timeFrame: Up to 15 days after the surgery.
Secondary outcomes:
measure: Postoperative Rescue Analgesic Requirement
timeFrame: Up to three days after surgery
measure: Postoperative nausea, retching and vomiting
timeFrame: Up to 3 days after surgery.
measure: Time to first mobilization
timeFrame: Up to 24 hours after surgery.
measure: Time to discharge
timeFrame: Trough hospital stay, an average of 1 week.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Ersin Koksal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
citation: 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.
citation: 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.
citation: 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.
citation: 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.