Topical Anaesthesia in Cutaneous Head and Neck Surgery

University Hospital Waterford

Status: Completed

Conditions: Cutaneous Tumor; Pain, Acute; Head and Neck Cancer

Treatments: Drug: EMLA; Drug: Aqueous cream BP; Drug: Ethyl chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06274905

160123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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124 participants in 4 patient groups, including a placebo group

EMLA cream

Experimental group

Description:

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

Treatment:

Drug: EMLA

EMLA placebo

Placebo Comparator group

Description:

Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study

Treatment:

Drug: Aqueous cream BP

Ethyl chloride spray

Experimental group

Description:

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.

Treatment:

Drug: Ethyl chloride

Control group

No Intervention group

Description:

No intervention administered