Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery
Conditions
Brief summary
To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.
Interventions
DEVICEStandard cold carbon dioxide gas
Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
DEVICEHeated humidified carbon dioxide gas
Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.
Sponsors
Fevzi Shakir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over 18 years of age * Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial. * Capacity to consent
Exclusion criteria
* Patients unable to speak English * Patients unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder tip pain | 8 hours | Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General abdominal pain, nausea, vomiting and analgesia requirements | 8 hours | General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline |
| Shoulder tip pain, general abdominal pain, nausea, vomiting. | 7 days | Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline |
Countries
United Kingdom
Contacts
Primary ContactFevzi Shakir, MBBS BSc MRCOG
Backup ContactAndrew Kent, TD MD FRCOG
Outcome results
None listed