The effect of cryoanalgesia on pain perception during infiltration of local anaesthetic agents: a randomised double blind controlled trial

ISRCTN	ISRCTN58354123
DOI	https://doi.org/10.1186/ISRCTN58354123
Secondary identifying numbers	N0515154546

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Raj Bhutiani
Scientific

Department of Surgery
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

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	Does cryoanalgesia used prior to injection of local anaesthetic agent, reduce pain perception during inflitration of the agents?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2004
Completion date	30/08/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2004
Date of final enrolment	30/08/2006

Department of Surgery

Harrow
HA1 3UJ
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

North West London Hospitals NHS Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2007		Yes	No