A study to investigate the effect of heating and humidifying laparoscopic insufflation gas on post laparoscopic pain

ISRCTN	ISRCTN27431428
DOI	https://doi.org/10.1186/ISRCTN27431428
Protocol serial number	N0084113224
Sponsor	Department of Health (UK)
Funder	The North and South Bank Research and Development Consortium (UK)

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

Ms Teresa Doto
Scientific

Hull and East Yorks Hospital Trust
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Post-operative shoulder tip pain.
Key secondary outcome measure(s)	Analgesia used and the length of time taken to return to normal activities.
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/01/2002
Date of final enrolment	01/12/2005

Hull and East Yorks Hospital Trust

Hull
HU8 9HE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan