postoperative pain MedDRA version: 9.1 Level: LLT Classification code 10064882 Term: Procedural pain
Conditions
Interventions
Trade Name: OSSICODONE CLORIDRATO
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: OXICODONE CLORIDRATO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age between 18 and 70 years, ASA (American Society of Anaesthesiologists) I-II, elective laparoscopic cholecistectomy 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patients refusal, BMI (Body Mass Index)> 30 Kg/m2, pregnant women, patients with a history of drug or alcohol abuse, patients taking analgesics drugs, steroids, drugs acting at NMDA receptors, antiemetics and MAO inhibitors, patients with nausea and vomiting within 24 hours before anaesthesia or pre-existing chronic pain disorder or chronic inflammatory disease or psychiatric disorder or any contraindications to the self-administration of opioids (i.e. inability to understand PCA (patient controlled analgesia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to investigate if oxycontin administered before general anaesthesia may be effective for the prevention of hyperalgesia as nitrous oxide and if the oxycontin-nitrous oxide combination may enhance single (oxycontin or nitrous oxide) therapy efficacy in patients undergoing laparoscopic cholecistectomy.;Secondary Objective: nd;Primary end point(s): VAS (visual analogue score) at rest and after coughing, postoperative tramadol consumption administered by PCA (patient controlled analgesia). | — |
Countries
Italy
Outcome results
None listed