NCT03211455

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 17, 2026

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

May 31, 2017

Last Update Submit

February 13, 2026

Conditions

Morbid ObesityBariatric Surgery Candidate

Keywords

bariatric surgeryrehabilitationlidocaine

Outcome Measures

Primary Outcomes (1)

  • oxycodone consumption

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

    three days following surgery

Secondary Outcomes (6)

  • lidocaine plasma concentration

    during post anesthesia care unit stay (1 day)

  • hospital discharge check list

    three days following surgery

  • postoperative pain

    three days following surgery

  • nausea and vomiting

    three days following surgery

  • intestinal transit recovery

    three days following surgery

  • +1 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Drug: isotonic saline

Lidocaine

EXPERIMENTAL

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.

Drug: Lidocaine

Interventions

LidocaineDRUG

intravenous lidocaine versus placebo

Lidocaine
isotonic salineDRUG

intravenous isotonic saline

Also known as: saline
Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled bariatric surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Caen

Caen, 14033, France

Location

Related Publications (1)

  • Plass F, Nicolle C, Zamparini M, Al Issa G, Fiant AL, Le Roux Y, Gerard JL, Fischer MO, Alves A, Hanouz JL. Effect of intra-operative intravenous lidocaine on opioid consumption after bariatric surgery: a prospective, randomised, blinded, placebo-controlled study. Anaesthesia. 2021 Feb;76(2):189-198. doi: 10.1111/anae.15150. Epub 2020 Jun 21.

    PMID: 32564365RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

July 7, 2017

Study Start

December 1, 2017

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

February 17, 2026

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)