ObesityPhase 3SPIRALNCT02525016
Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
A Phase 3 study testing Blood sampling and Lidocaine in people with Obesity and Bariatric Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery. Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Blood sampling and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 3
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy
- Body mass index > = 40 kg/m2
- Informed consent signed
- Patient treated with intravenous administration of lidocaine
Who cannot join
- Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)
- Concomitant use of beta blocker and others anti arrhythmic drugs
- Cardiac or hepatic insufficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Département d'anesthésie réanimation
Lyon, 69437
About this study
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.
Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.
Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.
Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.
Investigators get approbation of local ethic committee for this work.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Blood sampling, Lidocaine
- Keywords
- Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| assessment of plasmatic lidocaine rate | Experimental | Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine Receives: Biological: Blood sampling; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic concentration of lidocaine
Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period.
First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration.
Measured: From bolus to day 1 after cessation of administration
Secondary outcomes (1)
occurence of adverse events related to lidocaine use
neurologic (seizure, dysgeusia, dizziness) or cardiologic events (atrio ventricular block, ventricular rhythm disorder) will be assessed after surgery, during hospitalization in post-operative room or intensive care unit.
Measured: Up to 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525016
- Sponsor's protocol ID
- 69HCL15_0057
- Acronym
- SPIRAL
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Carabalona JF, Delwarde B, Duclos A, Le Goff MC, Moulsma M, Citterio-Quentin A, Bouffard Y, Rimmele T. Serum Concentrations of Lidocaine During Bariatric Surgery. Anesth Analg. 2020 Jan;130(1):e5-e8. doi: 10.1213/ANE.0000000000003905.
PubMed 30399021
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02525016
- Acronym / sponsor ID
- SPIRAL / 69HCL15_0057
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Aug 2015 (estimated)
- 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.
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.
Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.
Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.
Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.
Investigators get approbation of local ethic committee for this work.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of plasmatic lidocaine rate | Experimental | Biological: Blood sampling, Drug: LidocainePatients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy
- Body mass index > = 40 kg/m2
- Informed consent signed
- Patient treated with intravenous administration of lidocaine
Key exclusion criteria (4 listed)
- Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)
- Concomitant use of beta blocker and others anti arrhythmic drugs
- Cardiac or hepatic insufficiency
- Pregnancy
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 |
|---|---|---|
| Blood sampling | Biological | assessment of plasmatic lidocaine rate |
| Lidocaine | Drug | assessment of plasmatic lidocaine rate |
Primary outcome
Plasmatic concentration of lidocaine
Time frame: From bolus to day 1 after cessation of administration
Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period. First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration.
1 secondary outcome
occurence of adverse events related to lidocaine use
Time frame: Up to 2 days after surgery
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 19 Dec 2025.
- Results publication: PubMed 30399021Carabalona JF, Delwarde B, Duclos A, Le Goff MC, Moulsma M, Citterio-Quentin A, Bouffard Y, Rimmele T. Serum Concentrations of Lidocaine During Bariatric Surgery. Anesth Analg. 2020 Jan;130(1):e5-e8. doi: 10.1213/ANE.0000000000003905.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood sampling and Lidocaine in people with Obesity and Bariatric Surgery, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 4 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 19 Dec 2025. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Plasmatic concentration of lidocaine (time frame: From bolus to day 1 after cessation of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02525016, which also lists 1 linked publication.
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 19 Dec 2025.