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Topical Anaesthesia in Cutaneous Head and Neck Surgery

Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06274905
Enrollment
124
Registered
2024-02-23
Start date
2023-02-20
Completion date
2023-07-07
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Head and Neck Cancer, Cutaneous Tumor

Brief 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.

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.

Interventions

DRUGEMLA

EMLA cream

Ethyl chloride

Aqueous cream

Sponsors

University Hospital Waterford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged at least 18 years * Receiving surgery to cutaneous tissues of the head and neck * Procedure performed under local anaesthetic

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreThe 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

Secondary

MeasureTime frameDescription
Patient satisfactionThe overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).Patient satisfaction measured on NRS scale of 1=not bad at all, to 10=worst experience imaginable recorded immediately postoperatively

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026