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 |
| Secondary identifying numbers | N0084113224 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Ms Teresa Doto
Scientific
Scientific
Hull and East Yorks Hospital Trust
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Post-operative shoulder tip pain. |
| Secondary outcome measures | Analgesia used and the length of time taken to return to normal activities. |
| Overall study start date | 31/01/2002 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull and East Yorks Hospital Trust
Hull
HU8 9HE
United Kingdom
HU8 9HE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
