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

NCT ID: NCT05591105

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-01-31

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.

Conditions

Pharmacological Action; Post Operative Pain; Opioid Use; Obesity, Morbid; Anesthesia Morbidity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A:

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

Control Group

Intervention Type: DRUG

At the end of surgery, they will continue receiving analgesia according the schedule and, addicionally, lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minute as part of postoperative analgesia.

Group B:

At the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes

Placebo

Intervention Type: DRUG

At the end of surgery, they will continue receiving analgesia according the schedule.

Interventions

Control Group

At the end of surgery, they will continue receiving analgesia according the schedule and, addicionally, lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minute as part of postoperative analgesia.

Intervention Type: DRUG

Placebo

At the end of surgery, they will continue receiving analgesia according the schedule.

Intervention Type: DRUG

Other Intervention Names

Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale; Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tiva Group

OTHER

Sponsor Role: lead

Responsible Party

Carolina Frederico

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina Frederico

Role: PRINCIPAL_INVESTIGATOR

Tivagrooup

Gregory Contreras-Pérez

Role: PRINCIPAL_INVESTIGATOR

Tiva Group

Locations

Carolina

Barcelona, , Spain

Countries

Spain

Other Identifiers

TIVA OFA Obese patients

Identifier Type: -

Identifier Source: org_study_id