A double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions

ISRCTN ISRCTN45404336
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

Heatherwood and Wexham Park Hospitals NHS Trust
Department of Plastic Surgery
Wexham Park Hospital
Wexham Street
Slough
SL2 4HL
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions
Study objectivesThe 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) studiedSigns and Symptoms: Pain
InterventionFollowing 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 typeProcedure/Surgery
Primary outcome measurePatient's post-operative use of morphine using a PCA (patient controlled analgesia) device.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2002
Completion date01/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaWomen 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 criteriaNot provided at time of registration
Date of first enrolment01/05/2002
Date of final enrolment01/05/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Heatherwood and Wexham Park Hospitals NHS Trust
Slough
SL2 4HL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Heatherwood and Wexham Park Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

No publications found in PubMed, verifying study status with principal investigator.