WoundsPhase 4NCT02584335

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

A Phase 4 study testing Lidocaine solution ("A") and Saline solution ("B") in people with Wounds and Local Anesthesia, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wounds, Local Anesthesia
What is being tested?: Lidocaine solution ("A") and Saline solution ("B")
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteSpain
Study dates: Jul 2015to Jun 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelone, 08907

Other trials in Spain

About this study

Official title: Randomised, Double-blind Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo

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.

Read the detailed description

The manipulation of the wounds for its treatment is a painful process and there is currently no marketed any topical drug to decrease this suffering.

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: Wounds, Local Anesthesia
Being tested: Lidocaine solution ("A"), Saline solution ("B")
Keywords: wound treatment, lidocaine, pain reduction, local anesthetic
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT02584335
Study group	Role	What they receive
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). Receives: 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. Receives: Drug: Saline solution ("B")

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
If the wound treatment is still painful after application the dampen gauzes with the third syringe content, each patient has prescribed a systemic analgesic to decrease the pain. It does not matter which analgesic, the only condition is that it can not be modified during the period of inclusion into the study, it is 6 consecutive wound treatments. 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.
The need of the systemic analgesic to decrease the pain, in spite of the topical solution contained in the three syringes, it is registered for each wound treatment. At the end of the study, the investigators, will assess the requirements of systemic analgesics and if it exists any relation with lidocaine solution or placebo solution.
Measured: 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.
If the wound treatment is still painful after application the dampen gauzes with the third syringe content, each patient has prescribed a systemic analgesic to decrease the pain. It does not matter which analgesic, the only condition is that it can not be modified during the period of inclusion into the study, it is 6 consecutive wound treatments. 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.
The VNS punctuation before and after systemic analgesic administration is registered. At the end of the study, the investigators will assess the efficacy (decrease VNS punctuation) of systemic analgesic comparing the VNS punctuation registered before and after the administration.
Measured: 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.
At Bellvitge University Hospital, the treatment prescription and administration has an electronic registration so, the investigators have the timing of administration registered at the computer.
The investigators will compare if the need of systemic analgesics decrease (need of administration or not need of administration) at 60 minutes after the procedure when lidocaine solution has been applied during the procedure comparing when placebo has been administrated.
Measured: 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.
All the patients have prescribed a fixed systemic analgesia and rescue systemic analgesia (only administrated if the patient has pain). At Bellvitge University Hospital, the treatment prescription and administration has an electronic registration so, the investigators have the drug, the dose, the route of administration (all this invariable during the patient is included into the study) and the timing registered at the computer.
The investigators will compare if the needs (number of doses) of rescue systemic analgesics decrease during the next 24 hours when lidocaine solution has been applied during the procedure comparing when placebo has been administrated.
Measured: 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 content of the syringes 1 and 2 will be always applied (the number 1 contains always saline solution to register the basal pain, and the syringe 2 is the study drug: lidocaine solution or saline solution, according to the random list) and the VNS punctuation is registered after both applications. If the procedure is still painful after the content of the syringe 2 application, the content of the syringe 3 is applied (it is always the same study drug that contents the syringe 2 for each procedure) and it is registered as well as the VNS punctuation given by the patient.
At the end of the study, the investigators will determine how many times it has been necessary to apply the third syringe to reduce the pain (less punctuation given in the VNS) and, doing this, determinate if it is necessary one or two applications of the study drug to reduce the pain.
Measured: 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 if any side effects is detected.
Registering if any side effect (local or systemic) appears during the procedures and comparing if any relation exists with lidocaine solution.
Seven days after the sixth procedure has been done, the investigators will contact with the patient to take care that any side effects has been detected.
Measured: The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to 7 days after the sixth wound treatment has been done; it is up to 26 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Jun 2016

First posted22 Oct 2015 (estimated)
Study startJul 2015
Primary completionMay 2016
Study completionJun 2016

Why it stopped: Difficulties with the recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for WoundsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02584335
Sponsor's protocol ID: 2013LIDO
Other IDs: 2013-005077-52
Status last verified: Mar 2018
First submitted: 9 Oct 2015
Last updated: 27 Mar 2018
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 16211339
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.
PubMed 18264061
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.
PubMed 17941883
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.
PubMed 10607341
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.
PubMed 12547053
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.
PubMed 17052535
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.
PubMed 20110079
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.
PubMed 20569291
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.
PubMed 9649697
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.
PubMed 10025747
Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.
PubMed 21781635
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.
PubMed 23152206
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.
PubMed 22777856
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.
PubMed 15866847
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.
PubMed 22243434

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-blind Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo
ClinicalTrials.gov ID: NCT02584335
Acronym / sponsor ID: 2013LIDO
Conditions: Wounds, Local Anesthesia
Keywords: wound treatment, lidocaine, pain reduction, local anesthetic
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulties with the recruitment
Enrolment: 7 participants (actual)
Lead sponsor: Hospital Universitari de BellvitgeUniversity, hospital or other
Study start: Jul 2015
Primary completion: May 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 22 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The manipulation of the wounds for its treatment is a painful process and there is currently no marketed any topical drug to decrease this suffering.

Comparing the procedures carried out after lidocaine solution with saline solution, the investigators will evaluate the reduction of pain in the wounds treatment.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lidocaine solution ("A")	Active comparator	Drug: 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).
Saline solution ("B")	Placebo comparator	Drug: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	Lidocaine solution ("A")
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.	Drug	Saline solution ("B")

Primary outcome

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

6 secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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 if any side effects is detected.
Time frame: The assessment is done six times (one for each wound treatment). The time frame ranges from the date of randomization to 7 days after the sixth wound treatment has been done; it is up to 26 days.

Results and safety

The study was stopped early (reason given: Difficulties with the recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
Results publication: PubMed 16211339Ozgocmen 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.
Results publication: PubMed 18264061Franz-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.
Results publication: PubMed 17941883Stahl 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.
Results publication: PubMed 10607341Boulinguez 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.
Results publication: PubMed 12547053Yamashita 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.
Results publication: PubMed 17052535Davis 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.
Results publication: PubMed 20110079Sliti 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.
Results publication: PubMed 20569291Claeys 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.
Results publication: PubMed 9649697Holst 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.
Results publication: PubMed 10025747Lok 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.
Results publication: PubMed 21781635Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.
Results publication: PubMed 23152206Briggs 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonia Dalmau, PhD principal investigator

Hospital Universitari de Bellvitge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine solution ("A") and Saline solution ("B") in people with Wounds and Local Anesthesia, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties with the recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Register the VNS punctuation during wound treatments to demonstrate pain reduction (less VNS punctuation) when lidocaine solution has been administrated comparing to placebo. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584335, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.