Pain, PostoperativePhase 4NCT04584749
Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery
A Phase 4 study testing Lidocaine Iv in people with Pain, Postoperative, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine Iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 16 Nov 2020to 1 Apr 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the University of Girona Dr Josep Trueta.
- Accept and sign the informed consent
Who cannot join
- decline participating in the study at any stage of its development.
- History of allergic or adverse reactions to Amide-type anesthetics.
- Pregnancy or lactation period
- Diagnosis of Child-Pugh stage B or C liver failure.
- Acute renal failure (GFR <60 ml / min).
- Concomitant treatment with opioids for chronic pain.
- Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery
The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach
Read the detailed description
In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.
More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.
This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine Iv
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IvDrug
2% lidocaine or 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine.
20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine .
| Study group | Role | What they receive |
|---|---|---|
| LIDOCAINE | Experimental | 2% lidocaine will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine.
The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient Receives: Drug: Lidocaine Iv |
| PLACEBO | Placebo comparator | 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction . After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine/placebo.
The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing Physiological Serum as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient Receives: Drug: Lidocaine Iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
- evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption
Measured: 24 Hours
Secondary outcomes (1)
Incidence of nausea and vomiting
Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Nov 2020
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Pla Escriva, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Guillem Pla, MD, Principal investigator, Hospital Dr Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584749
- Sponsor's protocol ID
- PROTOCOL LIDO
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04584749
- Acronym / sponsor ID
- PROTOCOL LIDO
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 14 Oct 2020 (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 aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach
Detailed description
In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.
More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.
This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
| Arm | Type | Receives |
|---|---|---|
| LIDOCAINE | Experimental | Drug: Lidocaine Iv2% lidocaine will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient |
| PLACEBO | Placebo comparator | Drug: Lidocaine Iv0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction . After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine/placebo. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing Physiological Serum as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the University of Girona Dr Josep Trueta.
- Accept and sign the informed consent
Key exclusion criteria (7 listed)
- decline participating in the study at any stage of its development.
- History of allergic or adverse reactions to Amide-type anesthetics.
- Pregnancy or lactation period
- Diagnosis of Child-Pugh stage B or C liver failure.
- Acute renal failure (GFR <60 ml / min).
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 |
|---|---|---|
| Lidocaine Iv2% lidocaine or 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine. 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine . | Drug | LIDOCAINE, PLACEBO |
Primary outcome
Postoperative opioid consumption
Time frame: 24 Hours
o evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption
1 secondary outcome
Incidence of nausea and vomiting
Time frame: 24 hours
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 4 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Guillem Pla, MD principal investigator
Hospital Dr Josep Trueta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Iv in people with Pain, Postoperative, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta 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 2 inclusion and 7 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 4 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 opioid consumption (time frame: 24 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 4 Oct 2024.