Postoperative pain treatment following gynecologic surgery, using different doses of transdermal buprenorphine a double ? blind, randomized study - Transdermal buprenorphine for the treatment of postoperative pai

Conditions: Patients elected for laparotomic hysterectomy
MedDRA version: 9.1Level: LLTClassification code 10021151Term: Hysterectomy

Registration Number: EUCTR2008-003946-28-IT

Lead Sponsor: ISTITUTO PER L`INFANZIA BURLO GAROFOLO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

-Patients elective for laparotomic hysterectomy; -Age from 35 to 60 years; -Patients ASA I/II; -Patients can provide a written informed consent.
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

-Patients with age >35 and <60 years; -Patients with severe liver inssuficiency; -Patients with obesity (BMI> 27); -Patients with known hypersensitivity to buprenorphine or any other ingredients; -Patients addicted to opioids and in treatment of abstinence from drugs; -Patients with diseases in which the respiratory apparatus and respiratory function are severely compromised; -Patients who take or have taken MAO inhibitors in the last two weeks; -Patients who take opioids, antidepressants, hypnotics and/or NSAIDs; -Patients with psychiatric disorders; -Patients not cooperating and/or with psychological disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Verify the correlation between different doses and efficacy in postoperative pain of transdermal buprenorphine, following laparotomic hysterectomy. The efficacy will be assessed as dose/kg total of rescue medication administered during the 72 hours.;Secondary Objective: Parameters collected during the intraoperative period as the respiratory rate, blood pressure (systolic and diastolic) heart rate, oxygen saturation of blood and the BIS. During the post-operative period will be considered the pain expressed by the NRS (static and dynamic), the status of the patient and values of pressure and heart rate.;Primary end point(s): To evaluate the analgesic efficacy of TDS Buprenorphine the following parameters will be assessed: -Number of patients responding to treatment with NRS <4 and with minimal consumption of total rescue medication (2 mg/monodose)

Secondary Outcome Measures