Intravenous Lidocaine in Bariatric Surgery.
- Conditions
- Bariatric Surgery CandidateMorbid Obesity
- Interventions
- Drug: isotonic saline
- Registration Number
- NCT03211455
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- scheduled bariatric surgery
- any contra-indication for lidocaine administration
- pregnancy
- ASA class 4
- psychiatric disorder
- chronic opioid consumption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control isotonic saline 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. Lidocaine 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.
- Primary Outcome Measures
Name Time Method oxycodone consumption three days following surgery total postoperative (until day 3) oxycodone consumption (mg)
- Secondary Outcome Measures
Name Time Method hospital length of stay through hospital discharge (an average of 1 week) hospital length of stay
lidocaine plasma concentration during post anesthesia care unit stay (1 day) lidocaine plasma concentration measured at the end of infusion
postoperative pain three days following surgery postoperative pain intensity (visual analogue scale)
hospital discharge check list three days following surgery recovery (in days) which enable discharge from hospital
intestinal transit recovery three days following surgery duration (in days) of postoperative intestinal palsy
nausea and vomiting three days following surgery proportion of patients with and without postoperative nausea and vomiting
Trial Locations
- Locations (1)
University Hospital of Caen
🇫🇷Caen, France