Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146624
Study information
Scientific title
Acronym
Study hypothesis
To study the difference in distribution of anaesthetic fluid with and without hyaluronidase after sub-Tenon's block using B scan ultrasonography. Patients will be randomised to a group receiving local anaesthetic plus hyaluronidase. An ultrasound scan of the orbit will be performed prior to injection and 1, 3 and 5 minutes after injection to assess dispersal of local anaesthetic solution. The maximum depth of the local anaesthetic solution will be used to compare groups. The quality of the block will also be assessed in terms of akinesia, patient pre-operative pain sores and surgical assessment of the block.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
1. Anaesthetic fluid with hyaluronidase
2. Anaesthetic fluid without hyaluronidase
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Ultrasound measured depth of local anaesthetic solution behind the eye at 1, 3 and 5 minutes after the injection.
Secondary outcome measures
Akinesia, pain scores and surgical satisfaction.
Overall trial start date
24/03/2004
Overall trial end date
15/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive patients presenting for routine cataract extraction surgery will be approached to enrol in the study. They are mostly elderly patients (from previous studies in Leeds age range 65-80 years)
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Added December 2008: 19
Participant exclusion criteria
1. Allergy to local anaesthetic
2. Inability/refusal to give informed consent
3. Any patient with pre existing extra ocular muscle palsy, patients with single eye who could be unable to follow a target so assessment of akinesia would be impossible.
Recruitment start date
24/03/2004
Recruitment end date
15/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Metropolitan University
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK), own account
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17525774
Publication citations
-
Results
Khandwala M, Ahmed S, Goel S, Simmons IG, McLure HA, The effect of hyaluronidase on ultrasound-measured dispersal of local anaesthetic following sub-Tenon injection., Eye (Lond), 2008, 22, 8, 1065-1068, doi: 10.1038/sj.eye.6702860.