To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo
NCT ID: NCT02584335
Last Updated: 2018-03-27
Study Results
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Basic Information
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TERMINATED
PHASE4
7 participants
INTERVENTIONAL
2015-07-31
2016-06-30
Brief Summary
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Detailed Description
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The objective of this study is to demonstrate that lidocaine topical solution applied prior to wounds treatment, reduces the pain of the procedure compared to the treatment done after application of placebo solution. In addition, if the process was less painful, the consumption of systemic analgesics would be reduced (or eliminated) and, therefore, also its secondary effects.
It is a pilot, single-center clinical trial, prospective, randomised, double-blind, placebo-controlled study that will include 26 patients admitted in Bellvitge University Hospital (HUB) who present painful wound treatments.
The Pharmaceutical Department of HUB prepares a dilution of lidocaine 0.5% in 20ml disposable syringes and also identical disposable syringes containing 20ml saline solution (process authorized by the Spanish Agency of Medicines and Sanitary Products).
Each patient included will be subject to 6 procedures, randomised according to the sequence of treatment ABABAB or BABABA ("A" is lidocaine solution, "B" is placebo solution), according to a random list.
After a doctor of The Pain Department evaluates and includes the patient into the study, prescribes the treatment and the Pharmaceutical Department provides 3 identical syringes (numbered), for each procedure, to the nurse of the patient. The first syringe will contain always saline solution (this is unknown for the patient and the nurse) doing this, the investigators obtain the basal pain of each procedure. The other two syringes contain the studying solution (lidocaine or saline solution, according the sequence of the random list) but always the same solution in both.
The doctors of the Pain Department ask the patient about the pain before starting the procedure and determine according the "Verbal numerical scale" (VNS) from 0 to 10 points. The nurse, under sterile conditions, will dampen two sterile gauzes with the solution contained in the syringe 1, and will apply on the wound during 10 minutes before starting the treatment. After this time, the nurse starts the treatment of the wound and the doctor asks again about the pain punctuation on the VNS and register it. All this procedure is repeated with the contain of the syringe 2 and register the punctuation. If the procedure is still painful, the nurse applies (following the same procedure) gauzes with the solution contained in the syringe 3 and the doctor register the VNS punctuation. If even this third application, the treatment is still painful, each patient has prescribed a systemic analgesic to be used at this point if necessary (it does not matter which analgesic, the best for each patient, the only condition is that it can not be modified during the period of inclusion into the study, it is, 6 procedures) and the punctuation in the VNS is also registered. Furthermore, during each procedure, the nurse and the doctor, control the appearance of side effects and 7 days after the last procedure, the doctor contacts to the patient for check the clinical safety.
Comparing the procedures carried out after lidocaine solution with saline solution, the investigators will evaluate the reduction of pain in the wounds treatment.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Lidocaine solution ("A")
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).
Lidocaine solution ("A")
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.
Saline solution ("B")
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.
Saline solution ("B")
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.
Interventions
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Lidocaine solution ("A")
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.
Saline solution ("B")
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Antonia Dalmau Llitjos
PhD in Anesthesiology
Principal Investigators
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Antonia Dalmau, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelone, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2013-005077-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2013LIDO
Identifier Type: -
Identifier Source: org_study_id
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