Sponge anaesthesia versus topical anaesthesia for subconjunctival antibiotics/steroid injections in Phacoemulsification + Implant Surgery Study
| ISRCTN | ISRCTN51613333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51613333 |
| Secondary identifying numbers | N0265122364 |
- 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
Scientific
Ophthalmology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxybuprocaine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/01/2003 |
| Completion date | 16/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
