Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000453088
Ethics application status
Approved
Date submitted
14/05/2010
Date registered
3/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of a new less invasive technique of local anaesthesia for the eye in cataract surgery
Scientific title
Pilot study of Anterior Sub-Tenon Anaesthesia in cataract surgery, to assess quality of anaesthesia and akinesia.
Secondary ID [1] 251776 0
nil
Universal Trial Number (UTN)
U1111-1115-0174
Trial acronym
PASTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
new technique of eye anaesthesia for cataract surgery 257368 0
Condition category
Condition code
Anaesthesiology 257513 257513 0 0
Anaesthetics
Surgery 257659 257659 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A sub-Tenon regional block which is injected anterior to the equator of the globe without dissection, rather than the tradition injections posterior to the equator or after dissection. There are two comparison groups of either 2% Lignocaine or half/half solution of 0.5% Bupivacaine and 2% lignocaine. Total volume injected from 6-10mls. The injection it self takes 2-3 minutes, but including preparation and observation will take about 20 minutes.
Intervention code [1] 256475 0
Treatment: Drugs
Comparator / control treatment
The actual injection technique will be the same, requiring between 6-10mls of local anaesthetic, injected over about 2 minutes. However, one group will receive 2% Lignocaine, while the other group receives a half/half solution of 2% Lignocaine and 0.5% Bupivacaine.
Control group
Dose comparison

Outcomes
Primary outcome [1] 258431 0
To quantify motor movement of each rectus muscle and eye lid using Brahma akinesia score.
Timepoint [1] 258431 0
10 minutes after Anterior Sub-Tenon Anaesthesia (ASTA) injection
Secondary outcome [1] 264209 0
Verbal analogue pain score to assess pain
Timepoint [1] 264209 0
From the beginning to the end of surgery any pain which is observed by staff or surgeon or reported by the patient will be recorded. this usually occurs from about 20 minutes after ASTA injection, to about 1 hour from ASTA injection.

Eligibility
Key inclusion criteria
Elective patients requiring phaco cataract surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of patient consent, previous surgery to the posterior of the eye.

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)
Invitations with full study information are sent to elective patients due to have their surgery one month before. The Study nurse call patients 2 weeks before surgery to clarify any questions about the study and patients are left to sign the consent at home if they wish to. On the day of surgery, those who brought in consent forms are given ASTA injection. One of two types of anaesthetic solution is used by blindly picking a piece of paper from an envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will involve 60 patients, so 30 pieces of paper will have Lignocain written on it, the other 30 will have Lignocain/Bupivocaine written on it. Papers are then folded and picked out at random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256969 0
Self funded/Unfunded
Name [1] 256969 0
Dr Sharnie Wu
Country [1] 256969 0
Australia
Funding source category [2] 257091 0
Self funded/Unfunded
Name [2] 257091 0
Dr KC Tang
Country [2] 257091 0
Australia
Primary sponsor type
Individual
Name
Dr Sharnie Wu
Address
PO box 431 Lithgow, NSW, 2790
Country
Australia
Secondary sponsor category [1] 256230 0
Individual
Name [1] 256230 0
Dr KC Tang
Address [1] 256230 0
109 Sale St, Orange, NSW, 2800
Country [1] 256230 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258985 0
Sydney West Area Health Service Human Research Ethics Committee - Nepean Campus
Ethics committee address [1] 258985 0
Research Office
Ground Floor
Court Building
PO Box 63
PENRITH NSW 2751
Ethics committee country [1] 258985 0
Australia
Date submitted for ethics approval [1] 258985 0
12/02/2008
Approval date [1] 258985 0
29/07/2008
Ethics approval number [1] 258985 0
EC00151

Summary
Brief summary
Ophthalmic regional blocks are some of the most commonly used in Australia. yet most of them require blind insertions to the posterior of the eye. This study aims to study a new technique which injects under vision to the anterior of the eye. In theory this should be a simpler and safer technique. it's efficacy and safety will be the subject of this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31164 0
Address 31164 0
Country 31164 0
Phone 31164 0
Fax 31164 0
Email 31164 0
Contact person for public queries
Name 14411 0
Dr Sharnie Wu
Address 14411 0
PO Box 431 Lithgow, NSW 2790
Country 14411 0
Australia
Phone 14411 0
+61 438 525488
Fax 14411 0
+61 2 63523638
Email 14411 0
[email protected]
Contact person for scientific queries
Name 5339 0
Dr Sharnie Wu
Address 5339 0
PO B0x 431 Lithgow, NSW 2790
Country 5339 0
Australia
Phone 5339 0
+61 438525488
Fax 5339 0
+61 2 63523638
Email 5339 0
[email protected]

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.