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van CCT (UK)

van CCT (UK)

Upper eyelid anesthesia.

- candidate number14351
- NTR NumberNTR3847
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-feb-2013
- Secondary IDsNL41653.042.12 MEC UMC Groningen
- Public TitleUpper eyelid anesthesia.
- Scientific TitleComparison of pain on stunning of the upper eyelid skin in upper eyelid blepharoplasty with lidocaļne versus prilocaļne.
- hypothesisInjecting the upper eyelids with the anesthetic is experienced as quite painful by most patients. The acidity of the commonly used anesthetic Xylocaine is assumed to be the (main) cause of the pain. Citanest, the standard local anesthetic in dentistry, has a higher pH then Xylocaine and could therefore lead to less pain during stunning of the upper eyelids in upper eyelid blepharoplasty.
- Healt Condition(s) or Problem(s) studiedBlepharochalasis, Upper eyelid blepharoplasty, Anesthesia, Prilocaine
- Inclusion criteriaPatients with blepharochalasis, who will have an upper eyelid blepharoplasty for that purpose in the Bergman Clinics Heerenveen or Zwolle upward of the 1st of July 2013.
- Exclusion criteriaPrevious surgery on the upper eyelids, hypersensitivity to any component of Xylocaine 1%-Epinephrine or Citanest 3%-Octapressin or other local anesthetics of the amide type, congenital or idiopathic methaemoglobinaemia or inability to score pain using a Visual Analogue Scale (from 0 to 10).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2013
- planned closingdate31-dec-2014
- Target number of participants40
- InterventionsAll blepharoplasties will be performed by one of four plastic surgeons who work in the Bergman Clinics. In all participants one of the upper eyelids will be stunned 'standard' with Xylocaine 1%-Adrenaline (lidocainehydrochloride 10 mg/ml with epinephrine 5 µg/ml). The other upper eyelid will be injected with Citanest 3%-Octapressine (prilocainehydrochloride 30 mg/ml with felypressine 0,54 µg/ml). Drawing lots just before the operation will determine which upper eyelid will be injected with Xylocaine and which upper eyelid with Citanest.
For stunning, a 10 cc syringe is used with a 30G needle. Both anesthetics will be at room temperature, and are injected with a similar speed. In all participants, a volume of about 5 ml will be injected in each upper eyelid. If additional anesthetic is required or neccesary during the operation, this will be provided by the same anesthetic which is used initially.
- Primary outcomeThe pain experienced during infiltration of the anesthetic, will be scored by the participants on a Visual Analogue Scale from 0 to 10, with a score of 0 which means no pain and a score of 10 wich means unbearable pain.
- Secondary outcomeThe participant will be asked which upper eyelid was more painful during infiltration of the anesthetic: the first (right) upper eyelid, the second (left) upper eyelid, or no difference between the two upper eyelids. Besides that, the plastic surgeon will record for each upper eyelid the number of times that reinjection of anesthetic was needed during the operation (0x, 1x, 2x, etc.).
- TimepointsAfter injection of each upper eyelid, the participant will be asked to score the pain experienced on infiltration. So this will be asked twice in total (on the day of operation).
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe aim of this study is to investigate whether infiltration of the upper eyelid with Citanest is less painful then infiltration of the upper eyelid with Xylocaine. If this hypothesis proves to be correct, then in the future Citanest can be used in every upper eyelid blepharoplasty in order to reduce the pain on infiltration of the upper eyelids.
- Main changes (audit trail)
- RECORD10-feb-2013 - 19-feb-2013

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