University Hospital of Caen
Caen, 14033, France
NCT Number: NCT03211455
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
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Caen, 14033, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous lidocaine versus placebo
intravenous isotonic saline
Other names: saline
Time frame: three days following surgery
total postoperative (until day 3) oxycodone consumption (mg)
Time frame: during post anesthesia care unit stay (1 day)
lidocaine plasma concentration measured at the end of infusion
Time frame: three days following surgery
recovery (in days) which enable discharge from hospital
Time frame: three days following surgery
postoperative pain intensity (visual analogue scale)
Time frame: three days following surgery
proportion of patients with and without postoperative nausea and vomiting
Time frame: three days following surgery
duration (in days) of postoperative intestinal palsy
Time frame: through hospital discharge (an average of 1 week)
hospital length of stay
University Hospital, Caen
Other
Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
Acronym: XYLOBAR
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