Topical Anaesthesia in Cutaneous Head and Neck Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Pain, Acute; Cutaneous Tumor
• Intervention / Treatment: Drug: EMLA; Drug: Aqueous cream BP; Drug: Ethyl chloride

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMLA cream; 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	Drug: EMLA; EMLA cream
Placebo Comparator: EMLA placebo; Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study	Drug: Aqueous cream BP; Aqueous cream
Experimental: Ethyl chloride spray; 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.	Drug: Ethyl chloride; Ethyl chloride
No Intervention: Control group; No intervention administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: University Hospital Waterford

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Head and Neck Neoplasms; Acute Pain; Skin Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethyl Chloride
• Other Study ID Numbers: 160123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No