Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial
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
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
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
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
Rory O'Neill
Principal Investigator
University Hospital Waterford