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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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. |
|
| Control group | No Intervention | No intervention administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA | Drug | EMLA cream |
| |
| Ethyl chloride |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction measured on NRS scale of 1=not bad at all, to 10=worst experience imaginable recorded immediately postoperatively | The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Waterford | Waterford | X91 ER8E | Ireland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2022 | Feb 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D006258 | Head and Neck Neoplasms |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005018 | Ethyl Chloride |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.
| Drug |
Ethyl chloride |
|
| Aqueous cream BP | Drug | Aqueous cream |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |