Clinical trial NCT06274905: Topical Anaesthesia in Cutaneous Head and Neck Surgery
Official title: Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Head and Neck Cancer
Cutaneous Tumor
Lead sponsor: University Hospital Waterford
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain score
timeFrame: The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).
Secondary outcomes:
measure: Patient satisfaction
timeFrame: The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
References: