Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265122364
Study information
Scientific title
Sponge anaesthesia versus topical anaesthesia for subconjunctival antibiotics/steroid injections in Phacoemulsification + Implant Surgery Study
Acronym
Study hypothesis
Does the application of a pre-soaked oxybuprocaine swab on the conjunctiva reduce the pain of subconjunctival antibiotic/steroid injections more than topical oxybuprocaine alone?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Anaesthesia
Intervention
Prospective randomised control study of patients undergoing phacoemulsification and implant under topical anaesthesia at Sandwell and West Birmingham NHS Trust and University Hospital NHS Trust. Informed consent to be obtained from the patient before the operation.
They will be randomised into two groups:
Group 1 will have a pre-soaked oxybuprocaine sponge placed in the inferior conjunctival fornix at the beginning of the procedure.
Group 2 will have a saline soaked sponge.
Both groups having routine topical anaesthesia for cataract surgery. The patient will be advised before the injection of the subconjunctival antibiotic injection. 1 ml of cefuroxime/betamethasone (this is a routine preparation done on the completion of cataract surgery) will be given into the inferior conjunctival fornix.
The pain assessment will be assessed immediately after the operation by the patient and an independent observer. This will be done with the 0-10 visual analogue scale. The surgeon will also fill in a separate form regarding surgical time. We will then analyse the two groups to determine if a pre-soaked sponge of oxybuprocaine gives more pain relief than a pre-soaked sponge with saline. Both arms of the study will receive a normal anaesthetic to reduce pain.
Intervention type
Drug
Phase
Not Applicable
Drug names
Oxybuprocaine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/01/2003
Overall trial end date
16/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
To enroll 100 patients over 6 months
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/01/2003
Recruitment end date
16/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list