Symptomatic gallstone disease MedDRA version: 9.1 Level: LLT Classification code 10018109 Term: Generalized convulsive epilepsy MedDRA version: 9.1 Level: LLT Classification code 10007647 Term: Cardiovascular collapse MedDRA version: 9.1 Level: LLT Classification code 10002199 Term: Anaphylactic shock
Conditions
Interventions
Trade Name: Chirocaine
Product Name: chirocaine
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intraperito
Sponsors
Meander Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18-75 years with an ASA I or II classification who undergo elective laparoscopic cholecystectomy for symptomatic gallstone disease 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
Exclusion criteria: - Patients with cholecystitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer - Patients with a medical history of epilepsy, cardiac arrhytmias or chronical pain of any kind . - If a patient is allergic to drugs of the amid type. - Pregnancy - Subject suffering from hypotension or hypovolemia. - Subjects suffering from liver disease - Subject using drugs which deduce function of the CYP3A4 system like ketoconazol. - Subject using drugs which deduce function of the CYP1A2 system like the methylxanthines(Fluvoxamin enoxacin) - Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy;Secondary Objective: - Rescue analgesia treatment. Rescue analgesia will be given when the pain score (VAS) rises above 40. - Adverse events caused by the investigational procedure or by levobupivacaine itself. - Length of the surgical procedure - Length of hospital stay - Time to resumption of work or other usual daily activities - Development of postoperative complications during hospitalisation including pneumonia, thrombosis, urinary tract infections, wound abscess and bile leakage. - Development of intraoperative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures. ;Primary end point(s): The main endpoint is postoperative pain in VAS score (0-100). The VAS score is an international scoring system which scores pain from 0 to 100, in which 0 represents no pain and 100 is the worst pain imaginable. It usually consists of a 10-cm line, either vertical or horizontal, anchored at the ends by labels such as “no pain” and “worst possible pain.” Patients estimate the level of perceived pain by putting a mark on the line. The moments of recording in this study are based on resembling studies 30 min, 2h, 4h, 8h and 24h. At these points, the VAS scores of abdominal pain in rest, while coughing and in movement are scored by the patient at a VAS questionnaire. Beside the abdominal pain, the right shoulder pain will also be recorded. | — |
Countries
Netherlands
Outcome results
None listed