Morbid ObesityPhase 3XYLOBARNCT03211455
Intravenous Lidocaine in Bariatric Surgery.
A Phase 3 study testing Lidocaine and isotonic saline in people with Morbid Obesity and Bariatric Surgery Candidate, run by University Hospital, Caen at 1 site in France.
Trial summary
Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery Candidate
- What is being tested?
- Lidocaine and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 May 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled bariatric surgery
Who cannot join
- any contra-indication for lidocaine administration
- pregnancy
- ASA class 4
- psychiatric disorder
- chronic opioid consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown.
Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery
Read the detailed description
This is a prospective, double-blind, placebo-controlled, monocentric study. We plan to recruit 180 obese adult patients scheduled for bariatric surgery in a the french university hospital of Caen.
Exclusion: contra-indications for any aminoamide local anesthetic (allergy, severe hepatic disease) and for intravenous lidocaine (porphyria, atrioventricular conduction disturbances, uncontrolled seizure disease), long term opioid consumption, need for a post-operative follow-up in an intensive care unit, combined surgical procedure excepting cholecystectomy, pregnancy.
Patients will be randomly allocated to receive either a saline placebo or lidocaine continuous infusions during surgery. Morphinic consumption will be assessed from the end of the procedure until the third day after surgery. Secondary criteria will concern post-operative recovery, pain and postoperative nausea and vomiting, other medical and surgical complications, and toxicity. Plasma lidocaine concentrations will be measured in patients who had received lidocaine in order to determine the safety and efficiency of our infusion protocol.
Our analysis will be a superiority one, alpha risk is 5% and beta risk is 20%, in intention to treat, with no intermediate analysis.
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate
- Being tested
- Lidocaine, isotonic saline
- Keywords
- bariatric surgery, rehabilitation, lidocaine
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
intravenous lidocaine versus placebo
isotonic salineDrug
Also called saline
intravenous isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | intravenous isotonic saline administration : bolus of 0.075 ml/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (0.1 ml/kg/h, adjusted body weight) until the end of surgery decrease to 0.05 ml/kg (adjusted body weight) during 60 min in post anesthesia care unit.
Speed of infusion were calculated to be equivalent to that of lidocaine speed of injection. Receives: Drug: isotonic saline |
| Lidocaine | Experimental | Intravenous Lidocaine (20mg/ml) : bolus of 1.5 mg/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (2.0 mg/kg/h, adjusted body weight) until the end of surgery decrease to 1.0 mg/kg (adjusted body weight) during 60 min in post anesthesia care unit. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxycodone consumption
total postoperative (until day 3) oxycodone consumption (mg)
Measured: three days following surgery
Secondary outcomes (6)
lidocaine plasma concentration
lidocaine plasma concentration measured at the end of infusion
Measured: during post anesthesia care unit stay (1 day)
hospital discharge check list
recovery (in days) which enable discharge from hospital
Measured: three days following surgery
postoperative pain
postoperative pain intensity (visual analogue scale)
Measured: three days following surgery
nausea and vomiting
proportion of patients with and without postoperative nausea and vomiting
Measured: three days following surgery
intestinal transit recovery
duration (in days) of postoperative intestinal palsy
Measured: three days following surgery
hospital length of stay
hospital length of stay
Measured: through hospital discharge (an average of 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Dec 2017
- Primary completion1 Feb 2019
- Study completion1 May 2019
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 Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211455
- Sponsor's protocol ID
- 17-014
- Acronym
- XYLOBAR
- Status last verified
- Nov 2017
- First submitted
- 31 May 2017
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plass F, Nicolle C, Zamparini M, Al Issa G, Fiant AL, Le Roux Y, Gerard JL, Fischer MO, Alves A, Hanouz JL. Effect of intra-operative intravenous lidocaine on opioid consumption after bariatric surgery: a prospective, randomised, blinded, placebo-controlled study. Anaesthesia. 2021 Feb;76(2):189-198. doi: 10.1111/anae.15150. Epub 2020 Jun 21.
PubMed 32564365
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT03211455
- Acronym / sponsor ID
- XYLOBAR / 17-014
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, rehabilitation, lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 7 Jul 2017 (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.
Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown.
Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery
Detailed description
This is a prospective, double-blind, placebo-controlled, monocentric study. We plan to recruit 180 obese adult patients scheduled for bariatric surgery in a the french university hospital of Caen.
Exclusion: contra-indications for any aminoamide local anesthetic (allergy, severe hepatic disease) and for intravenous lidocaine (porphyria, atrioventricular conduction disturbances, uncontrolled seizure disease), long term opioid consumption, need for a post-operative follow-up in an intensive care unit, combined surgical procedure excepting cholecystectomy, pregnancy.
Patients will be randomly allocated to receive either a saline placebo or lidocaine continuous infusions during surgery. Morphinic consumption will be assessed from the end of the procedure until the third day after surgery. Secondary criteria will concern post-operative recovery, pain and postoperative nausea and vomiting, other medical and surgical complications, and toxicity. Plasma lidocaine concentrations will be measured in patients who had received lidocaine in order to determine the safety and efficiency of our infusion protocol.
Our analysis will be a superiority one, alpha risk is 5% and beta risk is 20%, in intention to treat, with no intermediate analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: isotonic salineintravenous isotonic saline administration : bolus of 0.075 ml/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (0.1 ml/kg/h, adjusted body weight) until the end of surgery decrease to 0.05 ml/kg (adjusted body weight) during 60 min in post anesthesia care unit. Speed of infusion were calculated to be equivalent to that of lidocaine speed of injection. |
| Lidocaine | Experimental | Drug: LidocaineIntravenous Lidocaine (20mg/ml) : bolus of 1.5 mg/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (2.0 mg/kg/h, adjusted body weight) until the end of surgery decrease to 1.0 mg/kg (adjusted body weight) during 60 min in post anesthesia care unit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled bariatric surgery
Key exclusion criteria (5 listed)
- any contra-indication for lidocaine administration
- pregnancy
- ASA class 4
- psychiatric disorder
- chronic opioid consumption
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 |
|---|---|---|
| Lidocaineintravenous lidocaine versus placebo | Drug | Lidocaine |
| isotonic salineAlso: salineintravenous isotonic saline | Drug | Control |
Primary outcome
oxycodone consumption
Time frame: three days following surgery
total postoperative (until day 3) oxycodone consumption (mg)
6 secondary outcomes
lidocaine plasma concentration
Time frame: during post anesthesia care unit stay (1 day)
hospital discharge check list
Time frame: three days following surgery
postoperative pain
Time frame: three days following surgery
nausea and vomiting
Time frame: three days following surgery
intestinal transit recovery
Time frame: three days following surgery
hospital length of stay
Time frame: through hospital discharge (an average of 1 week)
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 17 Feb 2026.
- Results publication: PubMed 32564365Plass F, Nicolle C, Zamparini M, Al Issa G, Fiant AL, Le Roux Y, Gerard JL, Fischer MO, Alves A, Hanouz JL. Effect of intra-operative intravenous lidocaine on opioid consumption after bariatric surgery: a prospective, randomised, blinded, placebo-controlled study. Anaesthesia. 2021 Feb;76(2):189-198. doi: 10.1111/anae.15150. Epub 2020 Jun 21.
- 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.
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 Lidocaine and isotonic saline in people with Morbid Obesity and Bariatric Surgery Candidate, run by University Hospital, Caen 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 1 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 17 Feb 2026. 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. 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 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?
oxycodone consumption (time frame: three days following surgery). 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 NCT03211455, 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 17 Feb 2026.