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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
Pennine Acute Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstone focused on measuring Gallstones, Gallbladder, Cholecystectomy, Gallstone disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 14, 2008
Last Updated
November 14, 2008
Sponsor
Pennine Acute Hospitals NHS Trust
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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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