Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084113224
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to find out if women will have less pain after their laparoscopy if the gas used during the operation is not as dry and contains more water.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
1. CO2 unheated and unhumified
2. CO2 heated but unhumified
3. CO2 unheated but humified
4. CO2 heated and humified
The surgeon, patient and main researcher will be blinded and only the anaesthetist will be aware of the gas used. In all cases the gas will be collected when the peritoneum is decompressed after surgery and the volume and water content measured as an estimate of water loss.
Post operative pain will be assessed using a visual response scale at 1, 2, 3 h and the evening of the operation and also the first, second and seventh day post laparoscopy. Responses will be requested for pain at the site of the wounds, pain in the pelvis and shoulder tip pain.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Post-operative shoulder tip pain.
Secondary outcome measures
Analgesia used and the length of time taken to return to normal activities.
Overall trial start date
31/01/2002
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women undergoing laparoscopic surgery for sterilisation or tubal patency testing will be given the opportunity to participate in the study. Subjects will be randomly allocated to one of the four groups.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/01/2002
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull and East Yorks Hospital Trust
Hull
HU8 9HE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The North and South Bank Research and Development Consortium (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