To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo.
NCT ID: NCT03676556
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
46 participants
INTERVENTIONAL
2021-06-16
2023-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo
NCT02584335
Lidocaine Analgesia For Removal Of Wound Vac Dressings
NCT01126359
Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser
NCT03366246
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
NCT01708447
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
NCT02086292
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 single-center clinical trial, prospective, randomised, double-blind, placebo-controlled study that will include 46 patients (23 lidocaine group, 23 placebo group) who presents painful wounds during treatment in the Bellvitge University Hospital (HUB) outpatients area.
The Pharmaceutical Department of HUB prepares a dilution of lidocaine 0.5% in 20ml disposable syringes and identical disposable syringes containing 20ml saline solution (process authorized by the Spanish Agency of Medicines and Sanitary Products).
When a patient arrives at the outpatient area (dermatology or plastic surgery departments) to treat a wound, the nursery or the doctor who does the procedure evaluates the pain during the treatment. If it is 5 or more points according the "Verbal Numerical Scale" (VNS), the nursery will explain to the patient the possibility of being a participant in this study, and give the information document. If the patient is interested, the doctor of the Pain Department will be warned and an EKG and a pregnancy test (if the patient is a woman in fertile age) will be done.
The doctor of the Pain Department will answer to any question about the study, will collect the medical record, will evaluate de EKG and the pregnancy test if it was done. Counting with all this information, and checking inclusion/exclusion criterias, the patient will be recluted. The patient will be ask to register in a data document any analgesic needed in the following 24 hours and also to register the VNS punctuation (0-10) 24 hours after the procedure, and to bring all this information the day of the next wound treatment. To avoid bias, the doctor of the Pain Department, will ask the patient to take the same analgesics the day of the study.
Between the basal wound treatment (it is, the day of the recruitment) and the wound treatment of the study (it will be the next wound treatment, when lidocaine or placebo will be applied, depending on the random list) there will not elapse more than 10 days.
The random process, will be done in the Pharmaceutical Department, following a table of random, starting at numer 01. The pair number will receive lidocaine, and the odd numbers saline solution. Each syringe will be named by an ordinary number, according with the recruitment number. And they will give this syringes to the outpatient area.
The day of the study, the nursery or the Pain Department doctor will record the VNS punctuation before treatment; then the nursery will apply wetted gauzes with the study solution and will wait 7-15 minutes to effect (exactly time counted and registrered with a chronometer). After this time the habitual treatment will be applied and at this moment the pain in the VNS will be recored. The nursery or the Pain Department doctor will be attentive to any secondary effect appears. And finally, the nursery will ask again about the pain 15 minutes after the procedure.
The nursery or the Pain Department doctor will ask to the patient to record the analgesics need in the following 24 hours and, after this period, the Pain Department doctor will call the patient to ask about this record, about the pain at 24 hours after the procedure and if any secondary effect has been detected.
Comparing the procedures carried out after lidocaine solution with saline solution, the investigators will evaluate the reduction of pain in the wounds treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Topical lidocaine
23 patients will recieve lidocaine solution before wound treatment
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.
Saline serum
23 patients will recieve saline solution before wound treatment
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitari de Bellvitge
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ana Sanchez Allueva
Anesthesiologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ana Sánchez Allueva
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
LIDO2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.