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

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

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Drug: Lidocaine = group A; Drug: Group B placebo

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by spray of lidocaïne during the insertion (group A = lidocaine)
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; Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	one time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one time

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: GOMERCIC Cecile, Ph, CHU de Nice, Hôpital Archet, Pôle Digestif, 151 route de saint-antoine de ginestière 06200 Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 26, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 13-AOI-12