None listed
Conditions
Interventions
Product Name: nitrous oxide medicinal
Product Code: 7
Pharmaceutical Form: Inhalation gas
Pharmaceutical form of the placebo: Inhalation gas
Route of administration of the placebo: Inhalation use
Sponsors
AIR LIQUIDE SANTE INTERNATIONAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - types of surgery interventions: major abdominal surgeries with laparotomy of expected length of 4 hours or even specified - adults: 18 to 65 years old - ASA 1-3 - signed patient consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Thoracic surgery - Psychotropic agent chronic usage - Chronic pain or chronic use of opioid analgesic - Preceding major abdominal surgery - Expected prolonged intubation - Radiation in the area of surgery - Regular intake of analgesics (except low dose acetylic acid for cardiovascular reasons) - Opioid intake 24 hours before surgery - Major obesity (BMI > 30) - Drug or alcohol abuse - Incapability of handling of PCA - Instable or significant central nervous system, cardiac, hepatic, renal or endocrine dysfunction and/or significant sequelas - Product-related exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the decrease of the postoperative morphine consumption by 30% in the treatment arm (N20/O2) vs treatment arm (N2/O2 and eventual additional sevofluran to obtain a BIS between 40 and 50) during 24 hours (primary outcome) and 72 hours (secondary outcome). ;Secondary Objective: - To demonstrate the reduction of the area of hyperalgesia to pin prick (by the Von Frey rigid filaments) around the surgical incision at 24, 48 and 72 hours in the treatment arm (N20/O2) vs control arm (N2/O2) - To emphasis the pain relief at movement (i.e. deep inspiration) at 24, 48 and 72 hours, using the VAS, in the treatment arm (N20/O2) vs treatment arm (N2/O2) - To demonstrate the prolongation of time to first morphine treatment in the treatment arm (N20/O2) - To compare the spontaneous pain assessment immediately before the start of morphine treatment (Verbal rating scale) - To compare the number of adverse events during the post operative period (72 hours) in the different groups -To evaluate the quality of life during a period of 12 months after treatment in both groups.;Primary end point(s): Consumption of morphine during 72 hours | — |
Countries
Austria, Belgium
Outcome results
None listed