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

Pennine Acute Hospitals NHS Trust

Status and phase: Unknown; Phase 4

Conditions: Gallstone

Treatments: Other: Cool dry C02; Other: Warm humidified C02

Study type: Interventional

Funder types: Other

Identifiers

NCT00792389

PAT-HWA-001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

1

Experimental group

Description:

Patients receiving warmed, humidified gas

Treatment:

Other: Warm humidified C02

2

Active Comparator group

Description:

Patients receiving cool, day gas

Treatment:

Other: Cool dry C02