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Trial registered on ANZCTR


Registration number
ACTRN12609000707268
Ethics application status
Not yet submitted
Date submitted
12/08/2009
Date registered
14/08/2009
Date last updated
14/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between sub-Tenon’s (parabulbar) with peribulbar anaesthesia for patients undergoing cataract extraction and placement of intraocular lens.
Scientific title
The effect of sub-Tenon's (parabulbar) compared with peribulbar (pericone) local anaesthesia on post-operative pain in patients undergoing cataract extraction and intraocular lens placement.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia in the first 24 hours post surgical cataract extraction 243514 0
Condition category
Condition code
Anaesthesiology 239810 239810 0 0
Pain management
Eye 239820 239820 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Peribulbar anaesthesia technique involves firstly anaesthetising the conjunctiva with oxybuprocaine hydrochloride 0.4%w/v drops. The eye and surrounding skin are sterilised with iodine solution. An injection of about 8mls of local anaesthetic solution (8ml 0.75% Ropivicaine, 2ml Xylocaine 10% and Hyalase 10units/ml solution) is given inferotemporal to the eye. Compression is applied on the eye to reduce raised intra-ocular pressure due to the volume of local anaesthetic being introduced. If the block is not adequate a second medial canthal injection can be added to produce an adequate block.

The cataract surgery takes about 45 minutes
Intervention code [1] 241122 0
Treatment: Other
Comparator / control treatment
Sub-Tenon's technique involves first anaesthetising the conjunctiva with oxybuprocaine hydrochloride 0.4%w/v drops. The eye and surrounding skin is sterilised, and an eye speculum is inserted. The patient is asked to look up and out to reveal the inferonasal quadrant of the conjunctiva, blunt forceps are used to lift the conjunctiva and Tenon’s fascia about 5mm from the limbus, Wescott scissors are used to snip the raised tent of conjunctiva and Tenon’s fascia to expose the sub-Tenon’s space. Closed Wescott scissors are passed in to the sub-Tenon’s space and used to blunt dissect posteriorly past the equator of the eye in to the posterior sub-Tenon’s space. A blunt cannula is passed in to the posterior sub-Tenon’s space and about 4-5ml of anaesthetic solution made up of 8ml 0.75% Ropivicaine, 2ml Xylocaine 10% and Hyalase 10units/ml solution is injected. The cannula is removed and the eye is lightly massaged for 2-3mins to aid in anaesthetic spread.

The cataract surgery takes about 45 minutes
Control group
Active

Outcomes
Primary outcome [1] 240572 0
Worst pain over 24hours post surgery as measured by visual analogue scale (VAS).
Timepoint [1] 240572 0
VAS measured at immediately post operative, 12 hrs, 24hrs and worst pain over the 24 hour period
Secondary outcome [1] 257216 0
Analgesic use over 24 hours post surgery is assessed by asking the patient to keep track of their analgesic use over the 24 hour period and providing this information at the post-operative visit.
Timepoint [1] 257216 0
24 hours post-operative at their first follow up visit.

Eligibility
Key inclusion criteria
Age: Over 18 years
Presenting for cataract surgery at the Royal Melbourne Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking
Axial length greater than 26mm
Unable to communicate with patients due to deafness or cognitive defecit
Patients on anti-coagulant medication
Uncontrolled hypertension >160/100

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237497 0
Hospital
Name [1] 237497 0
Royal Melbourne Hospital
Country [1] 237497 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
C/- Post office 3050
Royal Melbourne Hospital
Royal Parade
Parkville
Victoria
3050
Country
Australia
Secondary sponsor category [1] 236979 0
None
Name [1] 236979 0
Address [1] 236979 0
Country [1] 236979 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239617 0
Ethics committee address [1] 239617 0
Ethics committee country [1] 239617 0
Date submitted for ethics approval [1] 239617 0
28/08/2009
Approval date [1] 239617 0
Ethics approval number [1] 239617 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30046 0
Address 30046 0
Country 30046 0
Phone 30046 0
Fax 30046 0
Email 30046 0
Contact person for public queries
Name 13293 0
Dr Karl Alexander
Address 13293 0
c/- Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
c/- Post office 3050
Royal parade
Parkville
Victoria 3050
Country 13293 0
Australia
Phone 13293 0
+61 3 93427540
Fax 13293 0
Email 13293 0
karl.alexander@mh.org.au
Contact person for scientific queries
Name 4221 0
Dr Karl Alexander
Address 4221 0
c/- Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
c/- Post office 3050
Royal Parade
Parkville
Victoria 3050
Country 4221 0
Australia
Phone 4221 0
+61 3 93427540
Fax 4221 0
Email 4221 0
karl.alexander@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.