Analgesia Management in Bariatric Surgery

Not Applicable

Completed

• Conditions: Morbid Obesity; Bariatric Surgery Candidate; Pain; Postoperative
• Interventions: Drug: Lidocain; Drug: Ketamine; Drug: Dexmedetomidine

• Registration Number: NCT04836819
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-06
• Study Start: 2021-04-08
• Study First Posted: 2021-04-08
• Primary Completion: 2021-06-05
• Status Verified: 2021-07
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Lidocain	IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.
Group K	Ketamine	IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
Group D	Dexmedetomidine	IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.

Primary Outcome Measures

Name	Time	Method
Postoperative pain: VAS scores at rest and movement	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 Outcome Measures

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

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Atakum, Turkey