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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. The completion date has passed and the status has not been verified in more than two years.
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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?

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 ]

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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on June 21, 2017