Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms M Khandwala

ORCID ID

Contact details

Leeds Metropolitan University
48 Riding House Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 283 2600

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes