Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Teresa Doto

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes