Randomised, double-blind, placebo-controlled trial to identify any morphine-sparing effects of preoperative propacetamol in patients undergoing laparoscopic sterilisation by clip occlusion of fallopian tubes

ISRCTN ISRCTN30982801
DOI https://doi.org/10.1186/ISRCTN30982801
Secondary identifying numbers N0226107795
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
19/10/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Signs and Symptoms
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

Dr Neil Braude
Scientific

Department of Anaesthesia
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone +44 0161 291 2502
Email Neil.Braude@smuht.nwest.nhs.uk

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo demonstrate that preoperative administration of paracetamol (as intravenous propacetamol) in female patients undergoing laparoscopic sterilisation (by tubal clip occlusion) reduces postoperative morphine requirements.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
Intervention1. Propacetamol
2. Placebo

July 2008: trial stopped, drug no longer available and replaced by an alternative agent.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)propacetamol
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date30/09/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants40
Key inclusion criteria20 patients undergoing female laparoscopic sterilisation as a day-case and 20 controls.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2002
Date of final enrolment30/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
Manchester
M23 9LT
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

Government

South Manchester University 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