Pain, AcuteNCT06274905
Topical Anaesthesia in Cutaneous Head and Neck Surgery
A study testing EMLA, Ethyl chloride and Aqueous cream BP in people with Pain, Acute and Head and Neck Cancer, run by University Hospital Waterford at 1 site in Ireland.
Trial summary
This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Head and Neck Cancer, Cutaneous Tumor
- What is being tested?
- EMLA, Ethyl chloride and Aqueous cream BP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteIreland
- Study dates
- 20 Feb 2023to 7 Jul 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged at least 18 years
- Receiving surgery to cutaneous tissues of the head and neck
- Procedure performed under local anaesthetic
Who cannot join
- Paediatric patients
- Surgery performed under general anaesthetic
- Mucosal operative site (e.g. oral cavity)
- Significant cognitive impairment (e.g. severe dementia)
- Known sensitivity/allergy to EMLA
- History of a pain disorder (e.g. complex regional pain syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial
This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.
Read the detailed description
Operations on cutaneous tissues of the head and neck are some of the most frequently performed types of operation performed. They can often successfully be performed using local anaesthetic (LA). However, tissues in this anatomic area are some of most sensitive tissues in the body to nociceptive pain. As such, local anaesthetic can be a distressing experience for patients in many ways. Unfortunately, it is also the most common anatomical site for cutaneous malignancies. The majority of these lesions are resected under local anaesthetic. However, one of the major disadvantages of local anaesthetic such as lidocaine is pain during administration.
Several interventions have been used to reduce pain from needles and injections including ethylene chloride cryoanalgesic spray and topical anaesthetic agents including EMLA (lidocaine and prilocaine) and Ametop ointments. These have been extensively used in paediatric populations with great success to reduce pain during procedures requiring hypodermics such as cannulation. Several studies have trialled these interventions in adult populations across a variety of anatomical locations with variable results. The investigators aim to assess the efficacy of EMLA and ethyl chloride in mitigating nociceptive pain associated with local anaesthetic administration in patients undergoing cutaneous head and neck surgery.
- Conditions
- Pain, Acute, Head and Neck Cancer, Cutaneous Tumor
- Being tested
- EMLA, Ethyl chloride, Aqueous cream BP
- Medical subject headings
- Acute Pain, Head and Neck Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
EMLA cream
Ethyl chlorideDrug
Ethyl chloride
Aqueous cream BPDrug
Aqueous cream
| Study group | Role | What they receive |
|---|---|---|
| EMLA cream | Experimental | EMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study Receives: Drug: EMLA |
| EMLA placebo | Placebo comparator | Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study Receives: Drug: Aqueous cream BP |
| Ethyl chloride spray | Experimental | Ethyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate. Receives: Drug: Ethyl chloride |
| Control group | No intervention | No intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
The primary outcome measure is patient reported pain on a numeric rating scale (NRS)(1; no pain, 10; worst pain imaginable) recorded after LA administration
Measured: The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction measured on NRS scale of 1=not bad at all, to 10=worst experience imaginable recorded immediately postoperatively
Measured: The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 Feb 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Waterford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rory O'Neill, University Hospital Waterford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274905
- Sponsor's protocol ID
- 160123
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06274905
- Acronym / sponsor ID
- 160123
- Conditions
- Pain, Acute, Head and Neck Cancer, Cutaneous Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital WaterfordUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 23 Feb 2024 (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.
This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.
Detailed description
Operations on cutaneous tissues of the head and neck are some of the most frequently performed types of operation performed. They can often successfully be performed using local anaesthetic (LA). However, tissues in this anatomic area are some of most sensitive tissues in the body to nociceptive pain. As such, local anaesthetic can be a distressing experience for patients in many ways. Unfortunately, it is also the most common anatomical site for cutaneous malignancies. The majority of these lesions are resected under local anaesthetic. However, one of the major disadvantages of local anaesthetic such as lidocaine is pain during administration.
Several interventions have been used to reduce pain from needles and injections including ethylene chloride cryoanalgesic spray and topical anaesthetic agents including EMLA (lidocaine and prilocaine) and Ametop ointments. These have been extensively used in paediatric populations with great success to reduce pain during procedures requiring hypodermics such as cannulation. Several studies have trialled these interventions in adult populations across a variety of anatomical locations with variable results. The investigators aim to assess the efficacy of EMLA and ethyl chloride in mitigating nociceptive pain associated with local anaesthetic administration in patients undergoing cutaneous head and neck surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EMLA cream | Experimental | Drug: EMLAEMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study |
| EMLA placebo | Placebo comparator | Drug: Aqueous cream BPAqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study |
| Ethyl chloride spray | Experimental | Drug: Ethyl chlorideEthyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate. |
| Control group | No intervention | –No intervention administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged at least 18 years
- Receiving surgery to cutaneous tissues of the head and neck
- Procedure performed under local anaesthetic
Key exclusion criteria (6 listed)
- Paediatric patients
- Surgery performed under general anaesthetic
- Mucosal operative site (e.g. oral cavity)
- Significant cognitive impairment (e.g. severe dementia)
- Known sensitivity/allergy to EMLA
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 |
|---|---|---|
| EMLAEMLA cream | Drug | EMLA cream |
| Ethyl chlorideEthyl chloride | Drug | Ethyl chloride spray |
| Aqueous cream BPAqueous cream | Drug | EMLA placebo |
Primary outcome
Pain score
Time frame: The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).
The primary outcome measure is patient reported pain on a numeric rating scale (NRS)(1; no pain, 10; worst pain imaginable) recorded after LA administration
1 secondary outcome
Patient satisfaction
Time frame: The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).
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 23 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA, Ethyl chloride and Aqueous cream BP in people with Pain, Acute and Head and Neck Cancer, run by University Hospital Waterford at 1 site in Ireland.
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 3 inclusion and 6 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 23 Feb 2024. 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 Ireland. 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.
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?
Pain score (time frame: The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024.