Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0065149380
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the pain patients experience during cataract surgery with three different types of local anaesthesia, using two types of pain questionnaires (McGill pain questionnaire and visual analoque scale).
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Cataract
Intervention
A randomised, controlled trial comparing three types of anaesthesia: peribulbar, sub-tenon and topical.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Quality of pain control through cataract surgery with different types of anaesthetic. Assessment of pain the patients have with anaesthetic administration.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2004
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100 patients in each arm - 300
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2004
Recruitment end date
01/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
Sunderland
SR2 9HP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City Hospitals Sunderland NHS Trust R&D Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
2005 publication in Br J Ophthalmol. 2005 Sep;89(9):1228 entitled "Patient satisfaction with anaesthesia comparing sub-Tenon's block and topical anaesthesia" but no abstract available on http://www.ncbi.nlm.nih.gov/pubmed/16113395
Publication citations
-
Adams WE, Bell RW, Patient satisfaction with anaesthesia comparing sub-Tenon's block and topical anaesthesia., Br J Ophthalmol, 2005, 89, 9, 1228, doi: 10.1136/bjo.2005.075895.