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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Pennine Acute Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Pennine Acute Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00792389
First received: November 14, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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
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

  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
Royal Oldham Hospital Not yet recruiting
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

No publications provided

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

Keywords provided by Pennine Acute Hospitals NHS Trust:
Gallstones
Gallbladder
Cholecystectomy
Gallstone disease

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Pain, Postoperative
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
 Calculi
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013