Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies
Primary Purpose
Gallstone
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Warm humidified C02
Cool dry C02
Sponsored by
About this trial
This is an interventional treatment trial for Gallstone focused on measuring Gallstones, Gallbladder, Cholecystectomy, Gallstone disease
Eligibility Criteria
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
Sites / Locations
- Royal Oldham Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Patients receiving warmed, humidified gas
Patients receiving cool, day gas
Outcomes
Primary Outcome Measures
Total post operative opiate analgesia - morphine equivalent dose.
Secondary Outcome Measures
Subjective post operative pain as defined on numerical pain scales
Full Information
NCT ID
NCT00792389
First Posted
November 14, 2008
Last Updated
November 14, 2008
Sponsor
Pennine Acute Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00792389
Brief Title
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies
Official Title
Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pennine Acute Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone
Keywords
Gallstones, Gallbladder, Cholecystectomy, Gallstone disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving warmed, humidified gas
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients receiving cool, day gas
Intervention Type
Other
Intervention Name(s)
Warm humidified C02
Other Intervention Name(s)
Fisher Paykall laparoscopic humidifier
Intervention Description
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
Intervention Type
Other
Intervention Name(s)
Cool dry C02
Intervention Description
Insufflation of cool dry gas during laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Total post operative opiate analgesia - morphine equivalent dose.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Subjective post operative pain as defined on numerical pain scales
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie L Trevelyan, MBChB
Phone
01616200420
Ext
78985
Email
stephanie.trevelyan@pat.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Flook, MBChB
Organizational Affiliation
Pennine Acute Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Oldham Hospital
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies
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