The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery

Completed

• Conditions: Pharmacological Action; Post Operative Pain; Opioid Use; Obesity, Morbid; Anesthesia Morbidity
• Interventions: Drug: Control Group; Drug: Placebo

• Registration Number: NCT05591105
• Lead Sponsor: Tiva Group

Brief Summary

The goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to receive lidocaine and ketamine perfusion. The main question it aims to answer are: How lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? All participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group A: placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.

Detailed Description

The obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. An effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-24
• Study Start: 2023-06-15
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All patients between 18 y 65 years old.
• IMC > 30 kg/m2
• ASA II/III

Exclusion Criteria

• Patients taking high doses of opioids before operation for chronic pain
• Patients with allergies to any study medication.
• Pregnancy or breastfeeding.
• Kidney or heptic failure.
• Surgical complication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A:	Control Group	At the end of surgery, on the recovery room, this group will receive lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minutes
Group B:	Placebo	At the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	48 hours	The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.

Trial Locations

Locations (1)

Carolina; 🇪🇸 Barcelona, Spain