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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792389
Recruitment Status : Unknown
Verified November 2008 by Pennine Acute Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
Information provided by:
Pennine Acute Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Gallstone Other: Warm humidified C02 Other: Cool dry C02 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: 1
Patients receiving warmed, humidified gas
Other: Warm humidified C02
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
Other Name: Fisher Paykall laparoscopic humidifier

Active Comparator: 2
Patients receiving cool, day gas
Other: Cool dry C02
Insufflation of cool dry gas during laparoscopic cholecystectomy

Primary Outcome Measures :
  1. Total post operative opiate analgesia - morphine equivalent dose. [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Subjective post operative pain as defined on numerical pain scales [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792389

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Contact: Stephanie L Trevelyan, MBChB 01616200420 ext 78985

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United Kingdom
Royal Oldham Hospital
Oldham, Lancashire, United Kingdom, OL1 2JH
Sponsors and Collaborators
Pennine Acute Hospitals NHS Trust
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Principal Investigator: David Flook, MBChB Pennine Acute Hospital NHS Trust

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Responsible Party: Mr David Flook, Pennine Acute NHS Hospitals Trust Identifier: NCT00792389    
Other Study ID Numbers: PAT-HWA-001
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: November 17, 2008
Last Verified: November 2008
Keywords provided by Pennine Acute Hospitals NHS Trust:
Gallstone disease
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical