Pain, AcutePhase 4NCT03071601
Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department
A Phase 4 study testing Lidocaine-Prilocaine Cream 2.5-2.5% and Lidocaine 1% Epinephrine 0.005mg/mL solution in people with Pain, Acute and Laceration, run by Centre Hospitalier le Mans at 2 sites in France.
Trial summary
The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Laceration
- What is being tested?
- Lidocaine-Prilocaine Cream 2.5-2.5% and Lidocaine 1% Epinephrine 0.005mg/mL solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2017to 31 Dec 2021
- 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
- Superficial skin laceration requiring a suture
Who cannot join
- Known allergy to lidocaine
- Mucous membrane or eye wound
- Nose, ear or perineal wound
- Active hemorrhage in the wound
- Dirty or infected wound
- Wound requiring operation room management
Show all 14Show fewer
- Distracting pain in an other location
- Intoxicated or comatose patient
- Patient Under guardianship
- Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia
- Neurologic disorder affecting pain sensitivity
- Dementia
- Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age
- Absence of signed informed consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire Angers
Angers, 49 000
Centre Hospitalier Le Mans
Le Mans, 72 000
About this study
Official title: Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.
Read the detailed description
A prospective randomized open clinical trial conducted in two high volume emergency departments in France.
Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method.
126 patients are expected to enrol in the study.
- Conditions
- Pain, Acute, Laceration
- Being tested
- Lidocaine-Prilocaine Cream 2.5-2.5%, Lidocaine 1% Epinephrine 0.005mg/mL solution
- Keywords
- Laceration, Suture, Topical anesthesia, Lidocaine
- Medical subject headings
- Acute Pain, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-Prilocaine Cream 2.5-2.5%Drug
Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture
Lidocaine 1% Epinephrine 0.005mg/mL solutionDrug
Local anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthesia | Experimental | Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair. Receives: Drug: Lidocaine-Prilocaine Cream 2.5-2.5% |
| Subcutaneous injection anesthesia | Experimental | Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair. Receives: Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain
Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).
Measured: 60 minutes
Secondary outcomes (6)
Patient satisfaction
Patient satisfaction relating to the pain management measured on a four point Likert scale.
Measured: 60 minutes
Topical anesthesia failure rate
Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine
Measured: 60 minutes
Pain management during the various stages of care
Maximum pain measured on the numerical pain scale (0-10) measured on admission to the emergency department, during the wait for laceration treatment, during the wound cleansing for the intervention group and during anesthesia for the control group, during suture.
Measured: 60 minutes
Management duration
Mean duration of management between admission to the emergency department and discharge.
Measured: 60 minutes
Adverse effects
Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management
Measured: 15 days
Wound healing
Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers
- Responsible party
- Sponsor
- Investigators
- Julien Fonsegrive, MD, Principal investigator, Centre Hospitalier le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071601
- Sponsor's protocol ID
- CHM-2016-S2/04
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.
PubMed 22694845White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5. doi: 10.1097/01.pec.0000148029.61222.9f.
PubMed 15572968
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
- ClinicalTrials.gov ID
- NCT03071601
- Acronym / sponsor ID
- CHM-2016-S2/04
- Conditions
- Pain, Acute, Laceration
- Keywords
- Laceration, Suture, Topical anesthesia, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Collaborators
- University Hospital, Angers
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Mar 2017 (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 determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.
Detailed description
A prospective randomized open clinical trial conducted in two high volume emergency departments in France.
Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method.
126 patients are expected to enrol in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical anesthesia | Experimental | Drug: Lidocaine-Prilocaine Cream 2.5-2.5%Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair. |
| Subcutaneous injection anesthesia | Experimental | Drug: Lidocaine 1% Epinephrine 0.005mg/mL solutionLocal anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Superficial skin laceration requiring a suture
Key exclusion criteria (14 listed)
- Known allergy to lidocaine
- Mucous membrane or eye wound
- Nose, ear or perineal wound
- Active hemorrhage in the wound
- Dirty or infected wound
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-Prilocaine Cream 2.5-2.5%Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture | Drug | Topical anesthesia |
| Lidocaine 1% Epinephrine 0.005mg/mL solutionLocal anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound | Drug | Subcutaneous injection anesthesia |
Primary outcome
Maximum pain
Time frame: 60 minutes
Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).
6 secondary outcomes
Patient satisfaction
Time frame: 60 minutes
Topical anesthesia failure rate
Time frame: 60 minutes
Pain management during the various stages of care
Time frame: 60 minutes
Management duration
Time frame: 60 minutes
Adverse effects
Time frame: 15 days
Wound healing
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Results publication: PubMed 22694845McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.
- Results publication: PubMed 15572968White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5. doi: 10.1097/01.pec.0000148029.61222.9f.
- Individual participant dataSharing planned: No
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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.
Julien Fonsegrive, MD principal investigator
Centre Hospitalier le Mans
2 sites 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-Prilocaine Cream 2.5-2.5% and Lidocaine 1% Epinephrine 0.005mg/mL solution in people with Pain, Acute and Laceration, run by Centre Hospitalier le Mans at 2 sites in France.
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 1 inclusion and 14 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: finished, as of the sponsor's last update on 10 Mar 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 France. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum pain (time frame: 60 minutes). 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 NCT03071601, which also lists 2 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 10 Mar 2022.