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

November 14, 2008 updated by: Pennine Acute Hospitals NHS Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients receiving warmed, humidified gas
Other: Warm humidified C02
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
Other Names:
  • Fisher Paykall laparoscopic humidifier
Active Comparator: 2
Patients receiving cool, day gas
Other: Cool dry C02
Insufflation of cool dry gas during laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total post operative opiate analgesia - morphine equivalent dose.
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective post operative pain as defined on numerical pain scales
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennine Acute Hospitals NHS Trust

Investigators

  • Principal Investigator: David Flook, MBChB, Pennine Acute Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2008

Last Update Submitted That Met QC Criteria

November 14, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAT-HWA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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