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

NCT ID: NCT00792389

Last Updated: 2008-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gallstone

Keywords

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Gallstones Gallbladder Cholecystectomy Gallstone disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Patients receiving warmed, humidified gas

Group Type EXPERIMENTAL

Warm humidified C02

Intervention Type OTHER

Insufflation of warmed humidified gas during laparoscopic cholecystectomy

2

Patients receiving cool, day gas

Group Type ACTIVE_COMPARATOR

Cool dry C02

Intervention Type OTHER

Insufflation of cool dry gas during laparoscopic cholecystectomy

Interventions

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Warm humidified C02

Insufflation of warmed humidified gas during laparoscopic cholecystectomy

Intervention Type OTHER

Cool dry C02

Insufflation of cool dry gas during laparoscopic cholecystectomy

Intervention Type OTHER

Other Intervention Names

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Fisher Paykall laparoscopic humidifier

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennine Acute Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Pennine Acute NHS Hospitals Trust

Principal Investigators

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David Flook, MBChB

Role: PRINCIPAL_INVESTIGATOR

Pennine Acute Hospital NHS Trust

Locations

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Royal Oldham Hospital

Oldham, Lancashire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Stephanie L Trevelyan, MBChB

Role: CONTACT

Phone: 01616200420

Email: [email protected]

Other Identifiers

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PAT-HWA-001

Identifier Type: -

Identifier Source: org_study_id