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 |
| Protocol serial number | N0515154546 |
| Sponsor | Department of Health |
| Funder | North West London Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 20/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Raj Bhutiani
Scientific
Scientific
Department of Surgery
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Level of pain perception during infiltration of local anaesthetic agents and the operative procedure |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Surgery
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |
