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

Gallstone Clinical Trial

Official title:

Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00792389
• Other study ID #: PAT-HWA-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 14, 2008
• Last updated: November 14, 2008
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2008
• Source: Pennine Acute Hospitals NHS Trust
• Contact: Stephanie L Trevelyan, MBChB
• Phone: 01616200420
• Email: stephanie.trevelyan[@]pat.nhs.uk
• Is FDA regulated: No
• Health authority: UK:National Health ServiceUK:Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone
• Gallstones
• Pain, Postoperative

Intervention

Other:
• Warm humidified C02
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
• Cool dry C02
Insufflation of cool dry gas during laparoscopic cholecystectomy

Locations

Country	Name	City	State
United Kingdom	Royal Oldham Hospital	Oldham	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Pennine Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total post operative opiate analgesia - morphine equivalent dose.		1 day	No
Secondary	Subjective post operative pain as defined on numerical pain scales		1 day	No