Topical Anaesthesia in Cutaneous Head and Neck Surgery

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274905
• Other study ID #: 160123
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: February 2024
• Source: University Hospital Waterford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pain
• Cutaneous Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Pain, Acute
• Skin Neoplasms

Intervention

Drug:
• EMLA
EMLA cream
• Ethyl chloride
Ethyl chloride
• Aqueous cream BP
Aqueous cream

Locations

Country	Name	City	State
Ireland	University Hospital Waterford	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Waterford

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).