Sensory nerve block for upper lid surgery: a prospective randomised comparative study

ISRCTN ISRCTN00686968
DOI https://doi.org/10.1186/ISRCTN00686968
Protocol serial number N0214163271
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder The Royal Wolverhampton Hospitals NHS Trust (UK), NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
27/09/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A Kadyan
Scientific

The Wolverhampton & Midland Counties Eye Infirmary
Compton Road
Wolverhampton
WV3 9QR
United Kingdom

Email Anjukadyan@BTinternet.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo evaluate a combination regional block of the frontal and lacrimal nerves by the Hildreth-Silver technique for upper lid surgery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Eye
InterventionHildreth-Silver technique vs other technique

Added 09 September 2008: trial stopped due to unsatisfactory results.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Pain scores for injection and procedures, complications of anaesthesia, need for supplementary anaesthesia, levator function, patient co-operation score, surgical features, anaesthetic records

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2005
Reason abandoned (if study stopped)Unsatisfactory results

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration40
Key inclusion criteriaAny upper lid surgery suitable for local anaesthesia
Key exclusion criteria1. Age<16 years
2. Previous lid surgery
3. Difficulty in comprehension of study method or processes.
Date of first enrolment21/01/2005
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

The Wolverhampton & Midland Counties Eye Infirmary
Wolverhampton
WV3 9QR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan