WoundPhase 3NCT03676556
To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo.
A Phase 3 study testing Lidocaine and Saline Solution in people with Wound and Anesthesia, Local, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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
- Wound, Anesthesia, Local
- What is being tested?
- Lidocaine and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Jun 2021to Oct 2023
- Phase
- Phase 3
- 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.
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Ana Sánchez Allueva
L'Hospitalet de Llobregat, Barcelona, 08907
Ana Sanchez, Doctor, asancheza@bellvitgehospital.cat
- Not yet recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Ana Sanchez Allueva, Doctor, 0034932607500 ext. 7323, asancheza@bellvitgehospital.cat
Antonia Dalmau Llitjos, PhD, 0034932607500 ext. 7323, madalmau@bellvitgehospital.cat
About this study
Official title: Double-blind Randomized Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo, in the Outpatients Area.
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 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
- Wound, Anesthesia, Local
- Being tested
- Lidocaine, Saline Solution
- 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.
LidocaineDrug
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 SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical lidocaine | Active comparator | 23 patients will recieve lidocaine solution before wound treatment Receives: Drug: Lidocaine |
| Saline serum | Placebo comparator | 23 patients will recieve saline solution before wound treatment Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
We will register the VNS punctuation 15 minutes after wound treatment has finished, 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.
Measured: 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.
We will give to the patient a data document to register the VNS punctuation at 24 hours after each wound treatment of the study.
t the day of recruitment. The patient will give to the nursery this data document the day of the study treatment. 24 hours after the study treatment, the Pain Department doctor will call to the patient by phone, to get the same information than in the data document. We expect to obtain less VNS punctuation when lidocaine solution has been administrated vs saline solution.
Measured: 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.
Registering if any side effect (local or systemic) appears during each procedure and in the next 24 hours after each wound treatment.
Measured: 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)
The nursery will record the time of application of the wet gauzes with a chronometer. This time of application has to be always between 7 and 15 minutes.
Measured: Between 7 and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start16 Jun 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
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 WoundStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Sanchez Allueva, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676556
- Sponsor's protocol ID
- LIDO2017
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not give information to any other people
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 16211339Franz-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 18264061Stahl 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 17941883Boulinguez 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 10607341Yamashita 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 12547053Davis 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 17052535Sliti 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 20110079Claeys 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 20569291Holst 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 9649697Lok 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 10025747Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.
PubMed 21781635Briggs 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 23152206Brolmann 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 22777856Cooper 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 15866847Sobanko 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo, in the Outpatients Area.
- ClinicalTrials.gov ID
- NCT03676556
- Acronym / sponsor ID
- LIDO2017
- Conditions
- Wound, Anesthesia, Local
- Keywords
- wound treatment, lidocaine, pain reduction, local anesthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Sep 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical lidocaine | Active comparator | Drug: Lidocaine23 patients will recieve lidocaine solution before wound treatment |
| Saline serum | Placebo comparator | Drug: Saline Solution23 patients will recieve saline solution before wound treatment |
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.
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| LidocaineTwo 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. | Drug | Topical lidocaine |
| Saline SolutionTwo 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. | Drug | Saline serum |
Primary outcome
Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment.
Time frame: Maximum 10 days between the day of the recruitement and the treatment of the study.
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.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Between 7 and 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 21781635Bershow A, Warshaw E. Cutaneous reactions to transdermal therapeutic systems. Dermatitis. 2011 Jul-Aug;22(4):193-203.
- Background: 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.
- Individual participant dataSharing planned: No. We do not give information to any other people
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Saline Solution in people with Wound and Anesthesia, Local, run by Hospital Universitari de Bellvitge at 2 sites 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 12 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana S Sanchez, Doctor (0034932607500 ext. 7323, asancheza@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register the VNS (Verbal Numeric Scale) punctuation (between 0 it is not pain, and 10 it is unbearable pain) during wound treatment. (time frame: Maximum 10 days between the day of the recruitement and the treatment of the study.). 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 NCT03676556, 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 5 Aug 2022.