Bariatric Surgery Candidate, Morbid Obesity
Conditions
Keywords
bariatric surgery, rehabilitation, lidocaine
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.
Interventions
DRUGLidocaine
intravenous lidocaine versus placebo
DRUGisotonic saline
intravenous isotonic saline
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* scheduled bariatric surgery
Exclusion criteria
* any contra-indication for lidocaine administration * pregnancy * ASA class 4 * psychiatric disorder * chronic opioid consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxycodone consumption | three days following surgery | total postoperative (until day 3) oxycodone consumption (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lidocaine plasma concentration | during post anesthesia care unit stay (1 day) | lidocaine plasma concentration measured at the end of infusion |
| hospital discharge check list | three days following surgery | recovery (in days) which enable discharge from hospital |
| postoperative pain | three days following surgery | postoperative pain intensity (visual analogue scale) |
| nausea and vomiting | three days following surgery | proportion of patients with and without postoperative nausea and vomiting |
| intestinal transit recovery | three days following surgery | duration (in days) of postoperative intestinal palsy |
| hospital length of stay | through hospital discharge (an average of 1 week) | hospital length of stay |
Countries
France
Outcome results
None listed