The 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…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pain experienced during infiltration of the anesthetic, has been 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 outcome
- The participant is 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.
- The plastic surgeon will record for each upper eyelid the number of times
that reinjection of anesthetic was needed during the operation, written as 0x,
1x, 2x, etc.
- The plastic surgeon will also record which of the upper eyelids did bleed
more during surgery (right, left of no difference) and how much swelling (no,
slight, moderate of severe), redness (no, slight, moderate of severe) and/or
blue discoloration (no, minimal, moderate, severe) of the upper eyelids was
seen just after the operation.
Background summary
Upper blepharoplasty is one of the most commonly performed procedures by
plastic surgeons. Injecting 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.
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 blepharoplasty.
Study objective
The 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 blepharoplasty in order to reduce pain on
infiltration.
Study design
The study involves a patient-blinded randomized controlled trial.
All patients with blepharochalasis, who will have upper blepharoplasty in the
Bergman Clinics Heerenveen or Zwolle upward to the 1st of November 2013, will
be asked to participate in this study. When consent is obtained, drawing lots
just before the operation will determine which upper eyelid will be injected
with Xylocaine and which upper eyelid with Citanest. After injection of each
upper eyelid to the participant will be asked to score the pain experienced on
infiltration using a Visual Analogue Scale from 0 to 10, where 0 means no pain
and 10 means unbearable pain.
In addition, the participant is asked whether the pain on both upper eyelids
during infiltration of the anesthetic was similar whether the first (right) or
second (left) upper eyelid was more painful.
Finally, after the operation, the plastic surgeon will note if there was any
need to reinject one or both upper eyelid(s) during the procedure.
Intervention
In all participants one of the upper eyelids will be stunned 'standard' with 5
ml Xylocaine 1%-Adrenaline (lidocainehydrochloride 10 mg/ml with epinephrine 5
µg/ml). The other upper eyelid will be injected with 5 ml Citanest
%-Octapressine (prilocainehydrochloride 30 mg/ml with felypressine 0,54 µg/ml).
If additional anesthetic is required or neccesary during the operation, this is
provided by the same anesthetic which was used initially.
For stunning, a 10 cc syringe is used with a 30G needle. Both anesthetics are
at room temperature, and are injected with a similar speed. In all
participants, a volume of about 5 ml is injected in each upper eyelid.
Study burden and risks
No burden or time load is associated with participation in the study. After
injection of each upper eyelid, the participant will be asked to score the pain
experienced on infiltration using a Visual Analogue Scale from 0 to 10. So this
will be asked twice in total. In addition, the participant is asked once
(afterwards) whether the pain of both upper eyelids during infiltration of the
anesthetic was similar whether the first or second upper eyelid was more
painful.
Participation in the study does not affect the upper blepharoplasty that the
participant will have. Participants do not need to visit the clinic especially
for the study. In all participants one of the upper eyelids will be stunned
with the standard anaesthetic Xylocaine, while the other upper eyelid will be
injected with Citanest. It is possible that participants experience less pain
at the infiltration of one of the two upper eyelids. No adverse effects are
known of injecting the upper eyelid with Citanest.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patients with blepharochalasis who will have upper eyelid blepharoplasty for that purpose in the Bergman Clinics Heerenveen or Zwolle upward of the 1st of November 2013.
Exclusion criteria
- Previous 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
- Inability to score pain using a Visual Analogue Scale
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL41653.042.12 |
OMON | NL-OMON22369 |