Clinical trial NCT03211455: Intravenous Lidocaine in Bariatric Surgery.
Official title: Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Morbid Obesity
Bariatric Surgery Candidate
Keywords: bariatric surgery
rehabilitation
lidocaine
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* scheduled bariatric surgery

Exclusion Criteria:

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

Primary outcomes:
measure: oxycodone consumption
timeFrame: three days following surgery
Secondary outcomes:
measure: lidocaine plasma concentration
timeFrame: during post anesthesia care unit stay (1 day)
measure: hospital discharge check list
timeFrame: three days following surgery
measure: postoperative pain
timeFrame: three days following surgery
measure: nausea and vomiting
timeFrame: three days following surgery
measure: intestinal transit recovery
timeFrame: three days following surgery
measure: hospital length of stay
timeFrame: through hospital discharge (an average of 1 week)
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
References: