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OpenTrials
Completed

NCT Number: NCT03211455

Intravenous Lidocaine in Bariatric Surgery.

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Caen

Caen, 14033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • scheduled bariatric surgery

Exclusion criteria

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

Treatment and study plan

Lidocaine

Drug

intravenous lidocaine versus placebo

Isotonic saline

Drug

intravenous isotonic saline

Other names: saline

Primary outcomes

  1. oxycodone consumption

    Time frame: three days following surgery

    total postoperative (until day 3) oxycodone consumption (mg)

Secondary outcomes

  1. lidocaine plasma concentration

    Time frame: during post anesthesia care unit stay (1 day)

    lidocaine plasma concentration measured at the end of infusion

  2. hospital discharge check list

    Time frame: three days following surgery

    recovery (in days) which enable discharge from hospital

  3. postoperative pain

    Time frame: three days following surgery

    postoperative pain intensity (visual analogue scale)

  4. nausea and vomiting

    Time frame: three days following surgery

    proportion of patients with and without postoperative nausea and vomiting

  5. intestinal transit recovery

    Time frame: three days following surgery

    duration (in days) of postoperative intestinal palsy

  6. hospital length of stay

    Time frame: through hospital discharge (an average of 1 week)

    hospital length of stay

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: XYLOBAR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2017
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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