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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00792389

Enrollment

200

Registered

2008-11-17

Start date

2009-01-31

Completion date

2010-01-31

Last updated

2008-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstone

Keywords

Gallstones, Gallbladder, Cholecystectomy, Gallstone disease

Brief 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.

Interventions

OTHERWarm humidified C02

Insufflation of warmed humidified gas during laparoscopic cholecystectomy

OTHERCool dry C02

Insufflation of cool dry gas during laparoscopic cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total post operative opiate analgesia - morphine equivalent dose.	1 day

Secondary

Measure	Time frame
Subjective post operative pain as defined on numerical pain scales	1 day

Countries

United Kingdom

Contacts

Primary ContactStephanie L Trevelyan, MBChB

stephanie.trevelyan@pat.nhs.uk01616200420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026