Topical Anaesthesia in Cutaneous Head and Neck Surgery

Not Applicable

Completed

• Conditions: Pain, Acute; Head and Neck Cancer; Cutaneous Tumor
• Interventions: Drug: Aqueous cream BP; Drug: EMLA; Drug: Ethyl chloride

• Registration Number: NCT06274905
• Lead Sponsor: University Hospital Waterford

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.

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Study First Submitted: 2024-01-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EMLA placebo	Aqueous cream BP	Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study
EMLA cream	EMLA	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
Ethyl chloride spray	Ethyl chloride	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.

Primary Outcome Measures

Name	Time	Method
Pain score	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	The 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

Trial Locations

Locations (1)

University Hospital Waterford; 🇮🇪 Waterford, Ireland