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To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo.

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ClinicalTrials.gov Identifier: NCT03676556
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Sanchez Allueva, Hospital Universitari de Bellvitge

Brief Summary:
The purpose of this study is to evaluate if applying a lidocaine topical solution before wounds treatment decreases the pain of the procedure in comparison with placebo solution.

Condition or disease Intervention/treatment Phase
Wound Anesthesia, Local Drug: Lidocaine Drug: Saline Solution Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Double-blind Randomized Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo, in the Outpatients Area.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Topical lidocaine
23 patients will recieve lidocaine solution before wound treatment
Drug: Lidocaine
Two sterile gauzes will be dampen with the content of the syringe (20ml lidocaine 0.5%) and apply on the wound. After 7-15minutes of waiting to the effect, the wound treatment will start.

Placebo Comparator: Saline serum
23 patients will recieve saline solution before wound treatment
Drug: Saline Solution
Two sterile gauzes will be dampen with the content of the syringe (20ml saline serum) and apply on the wound. After 7-15minutes of waiting to the effect, the wound treatment will start.




Primary Outcome Measures :
  1. Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment. [ Time Frame: Maximum 10 days between the day of the recruitement and the treatment of the study. ]
    We will register the VNS punctuation during the wound treatment the day of the recruitment and also the day of study. We expect to obtain less punctuation when lidocaine solution has been administrated vs saline solution.


Secondary Outcome Measures :
  1. Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain)15 minutes after wound treatment has finished. [ Time Frame: 15 minutes after each wound treatment of the study has finished. ]
    We will register the VNS punctuation 15 minutes after wound treatment has finished, the day of the recruitment and also the day of study. We expect to obtain less punctuation when lidocaine solution has been administrated vs saline solution.

  2. Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) at 24 hours after each wound treatment of the study. [ Time Frame: At 24 hours after each wound treatment of the study ]

    We will give to the patient a data document to register the VNS punctuation at 24 hours after each wound treatment of the study.

    t the day of recruitment. The patient will give to the nursery this data document the day of the study treatment. 24 hours after the study treatment, the Pain Department doctor will call to the patient by phone, to get the same information than in the data document. We expect to obtain less VNS punctuation when lidocaine solution has been administrated vs saline solution.


  3. Register if appears any side effect: local (alterations in the skin, pruritus...) or systemic (tinnitus, metallic flavor, arrhythmia...) during each procedure and in the next 24 hours after each wound treatment. [ Time Frame: Up to 24 hours after each wound treatment of the study ]
    Registering if any side effect (local or systemic) appears during each procedure and in the next 24 hours after each wound treatment.

  4. Register the exact time to application of the wet gauzes with the study solution (between 7 and 15 minutes) [ Time Frame: Between 7 and 15 minutes ]
    The nursery will record the time of application of the wet gauzes with a chronometer. This time of application has to be always between 7 and 15 minutes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who has accepted and signed the informed consent before the random process.
  • Women or men aged more than 18 years
  • Patients with painful wound treatments (> or = 5) who come to outgoing area for the treatment
  • Wounds or sores of any aetiology sauf arterial deficit that implies at minimum dermis or epidermis, it is, II to IV degree in the Spanish Classification of Sores made by the "National Group to Study and Management of Pressure Ulcers and Chronic Wounds" (GNEAUPP).
  • Women in fertile age with pregnancy test negative

Exclusion Criteria:

  • Precedents of allergic reaction to local anesthesics type amides.
  • Wounds or sores degree I on the GNEAUPP Classification (it is, without discontinuity of skin).
  • Wounds or sores too large (which requirej more than 40 ml of solution to cover)
  • Wounds around the eyes
  • Wounds secondary to arterial deficit
  • Patients who presents disturbance of cardiac conduction: atrioventricular block (second or third degree) or bifascicular block
  • Patients with altered level of consciousness (Glasgow Coma Scale value less than 14)
  • Patients following hemodialysis, peritoneal dialysis or continuous hemofiltration treatment
  • Patients suffering moderate or severe hepatic insufficiency
  • Pregnant or lactating women
  • Once the patient has already participate in the study during a previous wound treatment
  • Patients who refuse to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676556


Contacts
Contact: Ana S Sanchez, Doctor 0034932607500 ext 7323 asancheza@bellvitgehospital.cat
Contact: Antonia D Dalmau, Doctor 0034932607500 ext 7323 madalmau@bellvitgehospital.cat

Locations
Spain
Hospital Universitari de Bellvitge Not yet recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Ana Sanchez Allueva, Doctor    0034932607500 ext 7323    asancheza@bellvitgehospital.cat   
Contact: Antonia Dalmau Llitjos, PhD    0034932607500 ext 7323    madalmau@bellvitgehospital.cat   
Principal Investigator: Ana Sanchez Allueva, Doctor         
Sub-Investigator: Antonia Dalmau Llitjos, PhD         
Sub-Investigator: Javier Bocos García, Doctor         
Sub-Investigator: Carmina Ribes Llario, Doctor         
Sub-Investigator: Stelania Savino, Doctor         
Sub-Investigator: María Valcarcel, Doctor         
Sub-Investigator: Peter Adamove, Doctor         
Sub-Investigator: Guillermo Puig, Doctor         
Sub-Investigator: Meritxell Sammpera, Nurse         
Sub-Investigator: José Antonio Palacín, Doctor         
Sponsors and Collaborators
Hospital Universitari de Bellvitge

Publications:

Responsible Party: Ana Sanchez Allueva, Anesthesiologist, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03676556     History of Changes
Other Study ID Numbers: LIDO2017
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not give information to any other people

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Sanchez Allueva, Hospital Universitari de Bellvitge:
wound treatment
lidocaine
pain reduction
local anesthetic

Additional relevant MeSH terms:
Wounds and Injuries
Pharmaceutical Solutions
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action