Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515154546
Study information
Scientific title
Acronym
Study hypothesis
Does cryoanalgesia used prior to injection of local anaesthetic agent, reduce pain perception during inflitration of the agents?
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
Signs and Symptoms: Pain
Intervention
Patients from one-stop hernia clinic will be given the research protocol information sheet on arrival (i.e. one hour prior to surgery). Surgeons will explain the research and the operation and obtain an informed consent, for both the operation and entry into the trial. Surgeons will answer any and every patient query regarding the trial and the operation. Patients will have the right to withdraw from the trial at any point without explanation. Patients will be randomised alternately into:
1. The control group
2. The trial group
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Level of pain perception during infiltration of local anaesthetic agents and the operative procedure
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2004
Overall trial end date
30/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients coming for hernia repairs under local anaesthetic in 'One-Stop Hernia Clinic' at ACAD will be requested to enter into trial on the day of arrival. Patient will be give complete information regarding the trial and will be explained that they are free no to enter if the so wish. Approximately 50 patients in each group.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2004
Recruitment end date
30/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Harrow
HA1 3UJ
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
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust (UK)
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
Basic results (scientific)
Publication list
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17567343
Publication citations
-
Results
Leff DR, Nortley M, Dang V, Bhutiani RP, The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial., Anaesthesia, 2007, 62, 7, 677-682, doi: 10.1111/j.1365-2044.2007.05056.x.