Patients elected for laparotomic hysterectomy MedDRA version: 9.1 Level: LLT Classification code 10021151 Term: Hysterectomy
Conditions
Interventions
Trade Name: TRANSTEC
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 17-
Trade Name: TRAN
Sponsors
ISTITUTO PER L`INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Patients with age >35 and 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed