The effect of hyaluronidase on dispersal of local anaesthetic solution after sub-Tenon's injection
| ISRCTN | ISRCTN74331160 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74331160 |
| Secondary identifying numbers | N0436146624 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 11/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms M Khandwala
Scientific
Scientific
Leeds Metropolitan University
48 Riding House Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 283 2600 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 24/03/2004 |
| Completion date | 15/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | Added December 2008: 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds Metropolitan University
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK), own account
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | Yes | No |
