The effect of hyaluronidase on dispersal of local anaesthetic solution after sub-Tenon's injection

ISRCTN	ISRCTN74331160
DOI	https://doi.org/10.1186/ISRCTN74331160
Protocol serial number	N0436146624
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK), own account

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms M Khandwala
Scientific

Leeds Metropolitan University
48 Riding House Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 283 2600

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	1. Anaesthetic fluid with hyaluronidase 2. Anaesthetic fluid without hyaluronidase
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Ultrasound measured depth of local anaesthetic solution behind the eye at 1, 3 and 5 minutes after the injection.
Key secondary outcome measure(s)	Akinesia, pain scores and surgical satisfaction.
Completion date	15/06/2004

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	19
Key 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)
Key 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.
Date of first enrolment	24/03/2004
Date of final enrolment	15/06/2004

Leeds Metropolitan University

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2008		Yes	No