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

NCT05591105 | Completed DMC

• 1 other identifier: TIVA OFA Obese patients
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.

  48 hours

Other Outcomes (1)

• Kind of surgery

  During surgery

Study Arms (2)

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

Group B:

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

Drug: Placebo

Interventions

Control Group 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.

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

Group A:

Placebo DRUG

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

Also known as: 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:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tiva Group: lead

Study Sites (1)

Carolina

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative; Obesity, Morbid

Interventions

Control Groups; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carolina Frederico

  Tivagrooup

  PRINCIPAL INVESTIGATOR

• Gregory Contreras-Pérez

  Tiva Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: June 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)