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Completed

NCT Number: NCT06274905

Topical Anaesthesia in Cutaneous Head and Neck Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Waterford

Waterford, X91 ER8E, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EMLA

Drug

EMLA cream

Ethyl chloride

Drug

Ethyl chloride

Aqueous cream BP

Drug

Aqueous cream

Primary outcomes

  1. Pain score

    Time frame: 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 outcomes

  1. Patient satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Waterford

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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