Morphine Consumption in the Obese Patients

Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Morbidity; Obesity, Morbid; Opioid Use; Post Operative Pain; Pharmacological Action
• Intervention / Treatment: Drug: Placebo; Drug: Control Group

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Carolina Frederico; Phone Number: +34622809851; Email: carolinafrederico@gmail.com
• Study Contact Backup: Name: Gregory Contreras-Pérez; Phone Number: +34 689656046; Email: jimjo2001@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Carolina

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Obese patient schedule to laparoscopic bariatric surgery since january 2022 until diciembre 2022 at Hospital HM Delfos Barcelona España.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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.; Other Names: Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale
Group B: At the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes	Drug: Placebo; At the end of surgery, they will continue receiving analgesia according the schedule.; Other Names: Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kind of surgery	The laparoscopic Sleeve Gastrectomy is technically more simple and shorter surgery time than the Roux-en-Y Gastric Bypass and maybe less painfull	During surgery

Collaborators and Investigators

• Sponsor: Tiva Group
• Investigators: Principal Investigator: Carolina Frederico, Tivagrooup; Principal Investigator: Gregory Contreras-Pérez, Tiva Group

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pain, Postoperative; Obesity, Morbid; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Dexketoprofen trometamol; Dipyrone
• Other Study ID Numbers: TIVA OFA Obese patients

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