Gallstone Clinical Trial
Official title:
Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?
Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - elective laparoscopic cholecystectomy - 18 years of age or over Exclusion Criteria: - under 18 years of age - prisoners - converted to open operation - secondary invasive procedure during operation - unable to give consent for whatever reason |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Oldham Hospital | Oldham | Lancashire |
Lead Sponsor | Collaborator |
---|---|
Pennine Acute Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total post operative opiate analgesia - morphine equivalent dose. | 1 day | No | |
Secondary | Subjective post operative pain as defined on numerical pain scales | 1 day | No |
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