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Intravenous Lidocaine in Bariatric Surgery. (XYLOBAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211455
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Caen.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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.

Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery


Condition or disease Intervention/treatment Phase
Morbid Obesity Bariatric Surgery Candidate Drug: Lidocaine Drug: isotonic saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control

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.

Drug: isotonic saline
intravenous isotonic saline
Other Name: saline

Experimental: Lidocaine
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.
Drug: Lidocaine
intravenous lidocaine versus placebo




Primary Outcome Measures :
  1. oxycodone consumption [ Time Frame: three days following surgery ]
    total postoperative (until day 3) oxycodone consumption (mg)


Secondary Outcome Measures :
  1. lidocaine plasma concentration [ Time Frame: during post anesthesia care unit stay (1 day) ]
    lidocaine plasma concentration measured at the end of infusion

  2. hospital discharge check list [ Time Frame: three days following surgery ]
    recovery (in days) which enable discharge from hospital

  3. postoperative pain [ Time Frame: three days following surgery ]
    postoperative pain intensity (visual analogue scale)

  4. nausea and vomiting [ Time Frame: three days following surgery ]
    proportion of patients with and without postoperative nausea and vomiting

  5. intestinal transit recovery [ Time Frame: three days following surgery ]
    duration (in days) of postoperative intestinal palsy

  6. hospital length of stay [ Time Frame: through hospital discharge (an average of 1 week) ]
    hospital length of stay



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled bariatric surgery

Exclusion Criteria:

  • any contra-indication for lidocaine administration
  • pregnancy
  • ASA class 4
  • psychiatric disorder
  • chronic opioid consumption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211455


Contacts
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Contact: fabien chaillot +33 2 31 06 57 81 chaillot-f@chu-caen.fr
Contact: fabien chaillot +33 2 31 06 57 81

Locations
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France
University Hospital of Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03211455    
Other Study ID Numbers: 17-014
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital, Caen:
bariatric surgery
rehabilitation
lidocaine
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action