Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr T Matthews

ORCID ID

Contact details

Ophthalmology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes