All patients that will undergo to an elective thoracotomic surgery in the Hospital ?Maggiore della Carita`? of Novara for a 12 months period. MedDRA version: 9.1 Level: SOC Classification code 10042613 MedDRA version: 9.1 Level: LLT Classification code 10052703
Conditions
Interventions
Trade Name: KETANEST S
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ketamine
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: equal
Concentration number: .5-
Pha
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient consent Age between 18 and 80 years ASA I, II, III Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergies to local anaesthetic drugs and/or opiates and/or ketamine Drug addiction Anomalies at coagulation tests Infections Renal Failure Liver Failure Cerebrovascoular diseases Neurological or psychiatric disorders Inability to collaborate because of physical or psychical deficit VEMS, CFV, FEV1, DLCO, <60% of physiological value Preoperative shoulder pathology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the use of ketamine (S) 0.1 mg/Kg/h in 60 hours in addition to the continuous administration of epidural analgesia (levobupivacaine 0.15 % and sufentanil at 5mcg/h) will decrease the incidence of post-surgical chronic pain management.;Secondary Objective: The study will investigate if ketamine has any effects in reducing the acute post-operative shoulder pain.;Primary end point(s): To evaluate the decrease of the incidence of post-surgical chronic pain management in a period of six months. | — |
Countries
Italy
Outcome results
None listed