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

NCT03676556 | Unknown Phase 3 DMC

• 1 other identifier: LIDO2017
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Wound; Anesthesia, Local

Keywords

wound treatment; lidocaine; pain reduction; local anesthetic

Outcome Measures

Primary Outcomes (1)

• Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment.

  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.

  Maximum 10 days between the day of the recruitement and the treatment of the study.

Secondary Outcomes (4)

• 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.

  15 minutes after each wound treatment of the study has finished.

• 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.

  At 24 hours after each wound treatment of the study

• 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.

  Up to 24 hours after each wound treatment of the study

• Register the exact time to application of the wet gauzes with the study solution (between 7 and 15 minutes)

  Between 7 and 15 minutes

Study Arms (2)

Topical lidocaine

ACTIVE COMPARATOR

23 patients will recieve lidocaine solution before wound treatment

Drug: Lidocaine

Saline serum

PLACEBO COMPARATOR

23 patients will recieve saline solution before wound treatment

Drug: Saline Solution

Interventions

Lidocaine DRUG

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.

Topical lidocaine

Saline Solution DRUG

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.

Saline serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (2)

Ana Sánchez Allueva

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

NOT YET RECRUITING

Related Publications (17)

• Ozgocmen S, Kaya A, Coskun BK. Topical lidocaine helps reduce pain of digital ulcers in systemic sclerosis (scleroderma). Clin Rheumatol. 2006 May;25(3):378-9. doi: 10.1007/s10067-005-0016-1. Epub 2005 Oct 7. No abstract available.

  PMID: 16211339 BACKGROUND

• Franz-Montan M, Ranali J, Ramacciato JC, de Andrade ED, Volpato MC, Groppo FC. Ulceration of gingival mucosa after topical application of EMLA: report of four cases. Br Dent J. 2008 Feb 9;204(3):133-4. doi: 10.1038/bdj.2008.48.

  PMID: 18264061 BACKGROUND

• Stahl M, Meyer C, Haas E, Glaenz T, Zutt M. Leg ulcer progression caused by topical anesthesia with EMLA cream. J Dtsch Dermatol Ges. 2008 Jul;6(7):566-8. doi: 10.1111/j.1610-0387.2007.06532.x. Epub 2007 Oct 17. English, German.

  PMID: 17941883 BACKGROUND

• Boulinguez S, Sparsa A, Bouyssou-Gauthier ML, Bedane C, Bonnetblanc JM. Adverse effects associated with EMLA cream used as topical anesthetic for the mechanical debridement of leg ulcers. J Am Acad Dermatol. 2000 Jan;42(1 Pt 1):146-8. doi: 10.1016/s0190-9622(00)90030-6. No abstract available.

  PMID: 10607341 BACKGROUND

• Yamashita S, Sato S, Kakiuchi Y, Miyabe M, Yamaguchi H. Lidocaine toxicity during frequent viscous lidocaine use for painful tongue ulcer. J Pain Symptom Manage. 2002 Nov;24(5):543-5. doi: 10.1016/s0885-3924(02)00498-0.

  PMID: 12547053 BACKGROUND

• Davis MD, Adams A. Lidocaine patch for the management of leg ulcer pain. J Am Acad Dermatol. 2006 Nov;55(5 Suppl):S126-7. doi: 10.1016/j.jaad.2006.02.056. No abstract available.

  PMID: 17052535 BACKGROUND

• Sliti N, Zaraa I, Daoud L, Trojett S, Letaief I, Mokni M, Jeddi A, Ben Osman A. [Acute bilateral palpebral necrosis: a rare complication of local anaesthesia]. Ann Dermatol Venereol. 2010 Jan;137(1):84-5. doi: 10.1016/j.annder.2009.10.001. Epub 2009 Nov 20. No abstract available. French.

  PMID: 20110079 BACKGROUND

• Claeys A, Gaudy-Marqueste C, Pauly V, Pelletier F, Truchetet F, Boye T, Aubin F, Schmutz JL, Grob JJ, Richard MA. Management of pain associated with debridement of leg ulcers: a randomized, multicentre, pilot study comparing nitrous oxide-oxygen mixture inhalation and lidocaine-prilocaine cream. J Eur Acad Dermatol Venereol. 2011 Feb;25(2):138-44. doi: 10.1111/j.1468-3083.2010.03720.x. Epub 2010 Jun 21.

  PMID: 20569291 BACKGROUND

• Holst RG, Kristofferson A. Lidocaine-prilocaine cream (EMLA Cream) as a topical anaesthetic for the cleansing of leg ulcers. The effect of length of application time. Eur J Dermatol. 1998 Jun;8(4):245-7.

  PMID: 9649697 BACKGROUND

• Lok C, Paul C, Amblard P, Bessis D, Debure C, Faivre B, Guillot B, Ortonne JP, Huledal G, Kalis B. EMLA cream as a topical anesthetic for the repeated mechanical debridement of venous leg ulcers: a double-blind, placebo-controlled study. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):208-13. doi: 10.1016/s0190-9622(99)70190-8.

  PMID: 10025747 BACKGROUND

• Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.

  PMID: 21781635 BACKGROUND

• Briggs M, Nelson EA, Martyn-St James M. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001177. doi: 10.1002/14651858.CD001177.pub3.

  PMID: 23152206 BACKGROUND

• Brolmann FE, Ubbink DT, Nelson EA, Munte K, van der Horst CM, Vermeulen H. Evidence-based decisions for local and systemic wound care. Br J Surg. 2012 Sep;99(9):1172-83. doi: 10.1002/bjs.8810. Epub 2012 Jul 6.

  PMID: 22777856 BACKGROUND

• Cooper SM, Hofman D, Burge SM. Leg ulcers and pain: a review. Int J Low Extrem Wounds. 2003 Dec;2(4):189-97. doi: 10.1177/1534734603260556.

  PMID: 15866847 BACKGROUND

• Sobanko JF, Miller CJ, Alster TS. Topical anesthetics for dermatologic procedures: a review. Dermatol Surg. 2012 May;38(5):709-21. doi: 10.1111/j.1524-4725.2011.02271.x. Epub 2012 Jan 13.

  PMID: 22243434 BACKGROUND

• Descroix V, Coudert AE, Vige A, Durand JP, Toupenay S, Molla M, Pompignoli M, Missika P, Allaert FA. Efficacy of topical 1% lidocaine in the symptomatic treatment of pain associated with oral mucosal trauma or minor oral aphthous ulcer: a randomized, double-blind, placebo-controlled, parallel-group, single-dose study. J Orofac Pain. 2011 Fall;25(4):327-32.

  PMID: 22247928 BACKGROUND

• Vanscheidt W, Sadjadi Z, Lillieborg S. EMLA anaesthetic cream for sharp leg ulcer debridement: a review of the clinical evidence for analgesic efficacy and tolerability. Eur J Dermatol. 2001 Mar-Apr;11(2):90-6.

  PMID: 11275800 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ana S Sanchez, Doctor

CONTACT

0034932607500; asancheza@bellvitgehospital.cat

Antonia D Dalmau, Doctor

CONTACT

0034932607500; madalmau@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: September 18, 2018
• Study Start: June 16, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)