Research with human participants

Overview of medical research in the Netherlands

The effect of lidocaine temperature on pain perception during infiltration for upper blepharoplasty: a blinded randomised trial comparing 21°C and 32°C solutions

Published:
Last updated:

To evaluate the effect of lidocaine temperature on pain perception during infiltration for upper blepharoplasty.

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruiting
Health condition type
Eye disorders NEC
Study type
Interventional

ID

NL-OMON49046

Source

ToetsingOnline

Brief title

The effect of lidocaine temperature on pain perception

Condition

  • Eye disorders NEC

Synonym

bilateral blepharoptosis, drooping eyelids

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Stichting Wetenschappelijk Onderzoek Oogziekenhuis

Intervention

Keyword :
lidocaine, local anesthesia, temperature, upper eyelid surgery

Outcome measures

Primary outcome

Pain during infiltration on a visual analogue scale.

Secondary outcome

Time course lidocaine preparation

Background summary

It has been reported that warming a local anaesthetic reduces pain during
infiltration.

Study objective

To evaluate the effect of lidocaine temperature on pain perception during
infiltration for upper blepharoplasty.

Study design

Randomised, comparative, single blinded study.

Intervention

Patients will be randomized between warm (32°C) versus ambient temperature
(21°C) anaesthetic solutions for infiltration in eyelid surgery.

Study burden and risks

Risks are negligible.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Age * 18 years
Bilateral upper blepharoplasty

Exclusion criteria

Previous surgical intervention to the eyelid(s)
Hypersensitivity to any of the contents of the local anaesthetic
Anxiety which requires tranquilizing or sedative agents prior to administering
the local anaesthetic

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active
Primary purpose :
Health services research

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
64
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 19869
Source: NTR
Title: The effect of lidocaine temperature on pain perception

In other registers

Register ID
CCMO NL67490.078.18
OMON NL-OMON19869