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临床试验/NCT06274905
NCT06274905已完成不适用

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

University Hospital Waterford1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
1
主要终点
Pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged at least 18 years
  • Receiving surgery to cutaneous tissues of the head and neck
  • Procedure performed under local anaesthetic

排除标准

  • 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).

研究组 & 干预措施

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

干预措施: 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

干预措施: 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.

干预措施: Ethyl chloride (Drug)

结局指标

主要结局

Pain score

时间窗: 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

次要结局

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

研究者

发起方
University Hospital Waterford
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rory O'Neill

Principal Investigator

University Hospital Waterford

研究点 (1)

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