patients undergoing to surgery for hip and knee prothesis (first implantation) MedDRA version: 9.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: CHIROCAINE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Levobupivacaine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients undergoing to surgery for hip and knee prothesis (first implantation) 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 affected by sense neuropathies, all patients not able for epidural catheter placement and all patients allergic to local anaesthetic or to opioid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify if the addition of an opiate drug to mixture administered by epidural procedure may be better for postoperative analgesia. This fact could reduce the use of e.v. morphina in postoperative analgesia.;Secondary Objective: To verify if the addition of an opiate drug to mixture administered by epidural procedure may be better for postoperative analgesia. This fact could reduce the use of e.v. morphina in postoperative analgesia.;Primary end point(s): addition of an opiate drug to mixture administered by epidural procedure may be better for postoperative analgesia. | — |
Countries
Italy
Outcome results
None listed