Pharmacological ActionNCT05591105
The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery
An observational study of Pharmacological Action and Post Operative Pain, run by Tiva Group at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pharmacological Action, Post Operative Pain, Opioid Use
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patient schedule to laparoscopic bariatric surgery since january 2022 until diciembre 2022 at Hospital HM Delfos Barcelona España.
Who may be able to join
- All patients between 18 y 65 years old.
- IMC > 30 kg/m2
- ASA II/III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Control Group, Placebo
- Medical subject headings
- Pain, Postoperative, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDrug
Also called Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale
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.
PlaceboDrug
Also called Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scale
At the end of surgery, they will continue receiving analgesia according the schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Jun 2023
- Primary completion30 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiva Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Frederico, Tiva Group
- Investigators
- Carolina Frederico, Principal investigator, TivagrooupGregory Contreras-Pérez, Principal investigator, Tiva Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591105
- Sponsor's protocol ID
- TIVA OFA Obese patients
- Status last verified
- Jul 2024
- First submitted
- 18 Oct 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion
- ClinicalTrials.gov ID
- NCT05591105
- Acronym / sponsor ID
- TIVA OFA Obese patients
- Conditions
- Pharmacological Action, Post Operative Pain, Opioid Use, Obesity, Morbid, Anesthesia Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tiva GroupUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: | – | Drug: Control GroupAt 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: | – | Drug: PlaceboAt the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patient schedule to laparoscopic bariatric surgery since january 2022 until diciembre 2022 at Hospital HM Delfos Barcelona España.
Key inclusion criteria (3 listed)
- All patients between 18 y 65 years old.
- IMC > 30 kg/m2
- ASA II/III
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupAlso: Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scaleAt 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. | Drug | Group A: |
| PlaceboAlso: Multimodal analgesia will be performed with paracetamol 1 gr, dexketoprofen 50 mg and metamizol 2 gr and morphine according to visual analogue scaleAt the end of surgery, they will continue receiving analgesia according the schedule. | Drug | Group B: |
Primary outcome
Postoperative morphine consumption
Time frame: 48 hours
The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Frederico principal investigator
Tivagrooup
Gregory Contreras-Pérez principal investigator
Tiva Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacological Action and Post Operative Pain, run by Tiva Group at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.