Sponge anaesthesia versus topical anaesthesia for subconjunctival antibiotics/steroid injections in Phacoemulsification + Implant Surgery Study

ISRCTN	ISRCTN51613333
DOI	https://doi.org/10.1186/ISRCTN51613333
Protocol serial number	N0265122364
Sponsor	Department of Health (UK)
Funder	University Hospital Birmingham NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 26/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr T Matthews
Scientific

Ophthalmology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Sponge anaesthesia versus topical anaesthesia for subconjunctival antibiotics/steroid injections in Phacoemulsification + Implant Surgery Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Oxybuprocaine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	16/07/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	To enroll 100 patients over 6 months
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/01/2003
Date of final enrolment	16/07/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Selly Oak Hospital

Birmingham
B29 6JD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes