CClinicalTrials.gg
CompletedNCT02022059XylonutUpdated Jun 1, 2022

Prospective Monocentric Study on the Efficacy of Lidocain Spray for Patient Comfort During Nasogastric Tube Insertion in Enteral Nutrition

A Phase 3 interventional study of Lidocaine = group A and Group B placebo in Undernutrition, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Centre Hospitalier Universitaire de Nice · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.

The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.

The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.

02

Conditions studied

  • Undernutrition

Browse trials for

03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 61 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • > 18 years
  • Patient needing enteral nutrition by NGT
  • Signed consentment
  • Affiliation to securite sociale

Exclusion criteria

Exclusion Criteria

  • Lidocaine allergy
  • Severe demencia
  • Non cooperating patient
  • Facial trauma and basal skull fracture
  • Reflex deglutition problem
  • Pulmonary illness like severe asthma
  • Hemodynamic instability
  • Pregnancy and nursing
  • Patient on guardianship
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Lidocaine

    patient nécessitant une SNG pour nutrition entérale bénéficiant d'une pré-médication par vaporisateur de lidocaïne lors de l'insertion (group A = lidcoaine)

    Drug: Lidocaine = group A

  • Placebo comparator
    Placebo

    Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion (group B)

    Drug: Group B placebo

Interventions

  • DrugLidocaine = group A

    Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by spray of lidocaïne during the insertion (group A = lidocaine)

  • DrugGroup B placebo

    Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion

06

What researchers measure

Primary outcomes

  1. EVA

    Pain and comfort during NGT insertion will be evaluate using visual analogue scale (0 to 100 mm marqued at each side: extreme pain and no pain).

    Time frame: one time

Secondary outcomes

  1. Scales

    * Nurse satisfaction using Likert scale from 1 to 5 * Patient satisfaction using Likert scale from 1 to 5 * Facility of NGT insertion using Likert scale from 1 to 5 and numbers of try: defined by numbers of insertions necessary by 1 operator. * Tolerance of the procedure: all complications will be note from beginning until 20 minutes. * Time for the NGT insertion defined like the number of minutes between the first attempt (when the nurse take the tube) until the end of the procedure. * Success of the insertion, defined by good insertion confirmed by an X-ray and procedure done by one operator.

    Time frame: one time

07

Study locations

1 site
  • CHU de Nice
    Nice, Alpes-Maritimes 06200, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02022059
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Dec 27, 2013
Start date
Dec 2013
Primary completion
Apr 2018
Completion
May 24, 2019
Last update
Jun 1, 2022

Study contacts

GOMERCIC Cecile, Ph
principal investigator · CHU de Nice, Hôpital Archet, Pôle Digestif, 151 route de saint-antoine de ginestière 06200 Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion