Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Raj Bhutiani

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17567343

Publication citations

  1. 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.

Additional files

Editorial Notes