Effect of preoperatively administered oxycontin and intraoperative nitrous oxide use on remifentanil-induced analgesia - ND

Conditions: postoperative pain
MedDRA version: 9.1Level: LLTClassification code 10064882Term: Procedural pain

Registration Number: EUCTR2008-005808-72-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures