Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies

This study is not yet open for participant recruitment.

Verified by Pennine Acute Hospitals NHS Trust, November 2008

Sponsored by:	Pennine Acute Hospitals NHS Trust
Information provided by:	Pennine Acute Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00792389

Purpose

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.

Condition	Intervention	Phase
Gallstone	Other: Warm humidified C02 Other: Cool dry C02	Phase IV

MedlinePlus related topics: Gallstones Gas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?

Further study details as provided by Pennine Acute Hospitals NHS Trust:

Primary Outcome Measures:

Total post operative opiate analgesia - morphine equivalent dose. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective post operative pain as defined on numerical pain scales [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving warmed, humidified gas	Other: Warm humidified C02 Insufflation of warmed humidified gas during laparoscopic cholecystectomy
2: Active Comparator Patients receiving cool, day gas	Other: Cool dry C02 Insufflation of cool dry gas during laparoscopic cholecystectomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792389

Contacts

Contact: Stephanie L Trevelyan, MBChB

01616200420 ext 78985

stephanie.trevelyan@pat.nhs.uk

Locations

United Kingdom, Lancashire
Royal Oldham Hospital
Oldham, Lancashire, United Kingdom, OL1 2JH

Sponsors and Collaborators

Pennine Acute Hospitals NHS Trust

Investigators

Principal Investigator:

David Flook, MBChB

Pennine Acute Hospital NHS Trust

More Information

Responsible Party:	Pennine Acute NHS Hospitals Trust ( Mr David Flook )
Study ID Numbers:	PAT-HWA-001
Study First Received:	November 14, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00792389
Health Authority:	UK:National Health Service; UK:Research Ethics Committee

Keywords provided by Pennine Acute Hospitals NHS Trust:

Gallstones
Gallbladder
Cholecystectomy
Gallstone disease

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Signs and Symptoms
Digestive System Diseases
Cholelithiasis

Postoperative Complications
Gallstones
Biliary Tract Diseases
Pain
Calculi
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009