Skip to main content
Clinical Trials/NCT06274905
NCT06274905
Completed
Not Applicable

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

University Hospital Waterford1 site in 1 country124 target enrollmentStarted: February 20, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University Hospital Waterford
Enrollment
124
Locations
1
Primary Endpoint
Pain score

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

EMLA cream

Experimental

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

Intervention: EMLA (Drug)

EMLA placebo

Placebo Comparator

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

Intervention: Aqueous cream BP (Drug)

Ethyl chloride spray

Experimental

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.

Intervention: Ethyl chloride (Drug)

Outcomes

Primary Outcomes

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

  • Patient satisfaction(The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).)

Investigators

Sponsor
University Hospital Waterford
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rory O'Neill

Principal Investigator

University Hospital Waterford

Study Sites (1)

Loading locations...

Similar Trials