Pain perception during infiltration of Lidocaine/Adrenaline for upper blepharoplasty at 37°C is reduced relative to infiltration at 21°C.
ID
Bron
Verkorte titel
Aandoening
Blepharoptosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain perception (VAS).
Achtergrond van het onderzoek
Rationale: It has been reported that warming a local anaesthetic reduces pain during infiltration.
Objective: To evaluate the effect of lidocaine temperature on pain perception during infiltration for upper blepharoplasty.
Study design: Randomised, comparative, single blinded study.
Study population: Patients 18 years or older admitted to our clinic for bilateral upper blepharoplasty.
Intervention: Patients will be randomized between warm (37°C) versus ambient temperature (21°C) anaesthetic solutions for infiltration in eyelid surgery.
Main study parameters/endpoints: Pain during infiltration on a visual analogue scale.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks are negligible.
Doel van het onderzoek
Pain perception during infiltration of Lidocaine/Adrenaline for upper blepharoplasty at 37°C is reduced relative to infiltration at 21°C.
Onderzoeksopzet
Preoperative.
Onderzoeksproduct en/of interventie
Prewarming of Lidocaine/Adrenaline.
Publiek
Rene Wubbels
010 4023430
r.wubbels@oogziekenhuis.nl
Wetenschappelijk
Rene Wubbels
010 4023430
r.wubbels@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age ≥ 18 years
Bilateral upper blepharoplasty
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Previous surgical intervention to the eyelid(s)
Hypersensitivity or other prior adverse effect to any of the contents of the local anaesthetic
Anxiety which requires tranquilizing or sedative agents prior to administering the local anaesthetic
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7577 |
| CCMO | NL67490.078.18 |
| OMON | NL-OMON49046 |