Intravenous Lidocaine in Bariatric Surgery. (XYLOBAR)
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|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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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.
intravenous lidocaine versus placebo
- oxycodone consumption [ Time Frame: three days following surgery ]total postoperative (until day 3) oxycodone consumption (mg)
- lidocaine plasma concentration [ Time Frame: during post anesthesia care unit stay (1 day) ]lidocaine plasma concentration measured at the end of infusion
- hospital discharge check list [ Time Frame: three days following surgery ]recovery (in days) which enable discharge from hospital
- postoperative pain [ Time Frame: three days following surgery ]postoperative pain intensity (visual analogue scale)
- nausea and vomiting [ Time Frame: three days following surgery ]proportion of patients with and without postoperative nausea and vomiting
- intestinal transit recovery [ Time Frame: three days following surgery ]duration (in days) of postoperative intestinal palsy
- hospital length of stay [ Time Frame: through hospital discharge (an average of 1 week) ]hospital length of stay
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
|Contact: fabien chaillot||+33 2 31 06 57 email@example.com|
|Contact: fabien chaillot||+33 2 31 06 57 81|
|University Hospital of Caen|
|Caen, France, 14033|