A double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions
ISRCTN | ISRCTN45404336 |
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DOI | https://doi.org/10.1186/ISRCTN45404336 |
Secondary identifying numbers | N0021122446 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Christopher Khoo
Scientific
Scientific
Heatherwood and Wexham Park Hospitals NHS Trust
Department of Plastic Surgery
Wexham Park Hospital
Wexham Street
Slough
SL2 4HL
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions |
Study objectives | The aim is to establish whether infiltrating the breast with a very low concentration of local anaesthetic solution reduces post-operative pain following breast reducing surgery. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
Intervention | Following induction of anaesthesia, 500 ml of a solution of adrenaline in normal saline (control) or bupivicaine plus adrenaline in normal saline (experimental) will be infiltrated into each breast. Both the patient and the surgeon will be blinded to the patient's trial group allocation. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Patient's post-operative use of morphine using a PCA (patient controlled analgesia) device. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/05/2002 |
Completion date | 01/05/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | Women aged 18 and over attending the Plastic Surgery Department at Wexham Park Hospital for breast reduction. Patient's with a history of substance abuse or who have a known allergy to the agents used will be excluded. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/05/2002 |
Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Heatherwood and Wexham Park Hospitals NHS Trust
Slough
SL2 4HL
United Kingdom
SL2 4HL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Hospital/treatment centre
Heatherwood and Wexham Park Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
No publications found in PubMed, verifying study status with principal investigator.