Intravenous Lidocaine in Bariatric Surgery.

Morbid Obesity Clinical Trial

— XYLOBAR  

Official title:

Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03211455
• Other study ID #: 17-014
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 31, 2017
• Last updated: July 12, 2017
• Start date: August 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2017
• Source: University Hospital, Caen
• Contact: fabien chaillot
• Phone: +33 2 31 06 57 81
• Email: chaillot-f[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• scheduled bariatric surgery

Exclusion Criteria:

• any contra-indication for lidocaine administration

• pregnancy

• ASA class 4

• psychiatric disorder

• chronic opioid consumption

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• Lidocaine
intravenous lidocaine versus placebo
• isotonic saline
intravenous isotonic saline

Locations

Country	Name	City	State
France	University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxycodone consumption	total postoperative (until day 3) oxycodone consumption (mg)	three days following surgery
Secondary	lidocaine plasma concentration	lidocaine plasma concentration measured at the end of infusion	during post anesthesia care unit stay (1 day)
Secondary	hospital discharge check list	recovery (in days) which enable discharge from hospital	three days following surgery
Secondary	postoperative pain	postoperative pain intensity (visual analogue scale)	three days following surgery
Secondary	nausea and vomiting	proportion of patients with and without postoperative nausea and vomiting	three days following surgery
Secondary	intestinal transit recovery	duration (in days) of postoperative intestinal palsy	three days following surgery
Secondary	hospital length of stay	hospital length of stay	through hospital discharge (an average of 1 week)