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

NCT02584335 | Terminated Phase 4 DMC

• 2 other identifiers: 2013LIDO2013-005077-52
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Wounds; Local Anesthesia

Keywords

wound treatment; lidocaine; pain reduction; local anesthetic

Outcome Measures

Primary Outcomes (1)

• Register the VNS punctuation during wound treatments to demonstrate pain reduction (less VNS punctuation) when lidocaine solution has been administrated comparing to placebo.

  The doctor asks to the patient about the punctuation on the VNS before touching the wound and when the wound treatment starts, it is, 10 minutes later than the dampen gauzes (with the syringe 1 content) has been applied on the wound and the VNS punctuation is registered. The nurse does the same procedure with the syringe 2 content and the VNS punctuation is registered. The syringe 3 content is only applied if the procedure is still painful, and the VNS punctuation is also registered. This process is done during 6 consecutive wound treatments for each patient. The time frame is up to 19 days because it depends on the need of treatment of each patient: every 24, 48 or 72 hours. At the end of the study, the investigators, will compare the punctuation registered when lidocaine solution has been administrated with the procedures realized when placebo solution was administrated, to demonstrate if the procedure is less painful (less VNS punctuation) when lidocaine solution was applied.

  The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to the date than the sixth wound treatment has been done; it is up to 19 days.

Secondary Outcomes (6)

• Register if systemic analgesics are required after the third syringe content application and compare if it decreases when lidocaine solution has been applied comparing to placebo.

  The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to the date than the sixth wound treatment has been done; it is up to 19 days.

• Register the efficacy (decrease VNS punctuation) of systemic analgesics when it has been required during the wound treatment.

  The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to the date than the sixth wound treatment has been done; it is up to 19 days.

• Register the requirements of systemic analgesics at 60 minutes after each procedure and compare if it decreases when lidocaine solution has been applied comparing to placebo.

  The assessment is done six times (60 minutes after each wound treatment). The time frame ranges from the date of randomization to the date than the sixth wound treatment has been done; it is up to 19 days.

• Register the number of doses of rescue systemic analgesics during the next 24 hours after each procedure and compare if it decreases when lidocaine solution has been applied comparing to placebo.

  The assessment is done six times (during the next 24h after each wound treatment). The time frame ranges from the date of randomization to the day after than the sixth wound treatment has been done; it is up to 20 days.

• Register the number of applications that it is necessary to decrease the pain (less punctuation in VNS) during the wound treatment procedure (it is: 1 or 2 applications).

  The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to the date than the sixth wound treatment has been done; it is up to 19 days.

Study Arms (2)

Lidocaine solution ("A")

ACTIVE COMPARATOR

Two sterile gauzes will be dampen with the content of the second syringe (the content of the first syringe is always 20 ml of saline solution and it is the first sterile gauzes administrated always) that will contain 20ml of 0.5% lidocaine dilution when the wound treatment process is assigned to the letter "A". The nurse has a third syringe exactly like this second syringe to apply if necessary (process still painful to the patient).

Drug: Lidocaine solution ("A")

Saline solution ("B")

PLACEBO COMPARATOR

Two sterile gauzes will be dampen with the content of the second syringe (the content of the first syringe is always 20 ml of saline solution and it is the first sterile gauzes administrated always) that will contain 20ml of saline solution when the wound treatment process is assigned to the letter "B". The nurse has a third syringe exactly like this second syringe to apply if necessary (process still painful to the patient). In this case, the three syringes supplied to the nurse, have saline solution.

Drug: Saline solution ("B")

Interventions

Lidocaine solution ("A") DRUG

Each of 26 patients will be evaluated during 6 consecutive wound treatments. The nurse will receive 3 syringes for each procedure, the syringe 1 always contains saline solution (blinded to the patient and to the nurse) to register the basal pain; the other two syringes are identical (number 2 and 3) and contain the study drug: lidocaine solution or saline solution. The investigators randomise the patients depending on the administration sequence (ABABAB or BABABA). When the procedure is "A", the nurse will receive the syringes number 2 and 3 containing lidocaine solution to apply (blinded to the nurse, the patient and the doctor). Note: The investigators consider important apply both treatments (lidocaine solution and saline solution) alternatively to avoid the bias that could might fall a cause of wound evolution (to heal or to get worse). And it is important that the same patient receives both treatments to decrease the subjective component in pain perception.

Lidocaine solution ("A")

Saline solution ("B") DRUG

Each of 26 patients will be evaluated during 6 consecutive wound treatments. The nurse will receive 3 syringes for each procedure, the syringe 1 always contains saline solution (blinded to the patient and to the nurse) to register the basal pain; the other two syringes are identical (number 2 and 3) and contain the study drug: lidocaine solution or saline solution. The investigators randomise the patients depending on the administration sequence (ABABAB or BABABA). When the procedure is "B", the nurse will receive the syringes number 2 and 3 containing saline solution to apply (blinded to the nurse, the patient and the doctor). Note: The investigators consider important apply both treatments (lidocaine solution and saline solution) alternatively to avoid the bias that could might fall a cause of wound evolution (to heal or to get worse). And it is important that the same patient receives both treatments to decrease the subjective component in pain perception.

Saline solution ("B")

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.
• Patients with painful wound treatments
• Wounds or sores of any aetiology (vascular insufficiency, diabetics, traumatic, postsurgical...) 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.
• Men and women in fertile age using contraceptive measures

You may not qualify if:

• Precedents of allergic reaction to local anesthesics type amides.
• Wounds or sores degree I on the GNEAUPP Classification (without discontinuity of skin).
• Wounds or sores too large (which require more than 40 ml of solution to cover).
• Wounds around the eyes.
• 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.
• Patients who refuse to participate in the study.
• Patients requiring wounds treatment more than once each day.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

Location

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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

  PMID: 21781635 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Antonia Dalmau, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Anesthesiology

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 22, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

ES (1)