Postoperative pain in patients undergoing laparoscopic cholecystectomy MedDRA version: 12.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief MedDRA version: 12.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia
Conditions
Interventions
Trade Name: Naropin
Product Name: Naropin
Product Code: 17971
Pharmaceutical Form: Solution for infusion
CAS Number: 132112357
Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Concentrati
Sponsors
Joergen B Dahl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing laparoscopic cholecystectomy Age 18 to 75 years ASA 1-3 BMI 18-35 written 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who dosent speak or understand Danish Relevant drug allergy Pregnancy Alchol- or drug abuse Daily opioate indtake Patients who have received NSAID, paracetamol or COx2 inhibitors 24 hours before the operation Infection at the injection site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Visual Analog Pain scores under coughing 0,2,4,6,8 and 24 hours postoperative;Primary end point(s): Pain score doring coughing (AUC/24 hours);Secondary Objective: Pain scores in rest 0,2,4,6,8 and 24 hours postoperative Morphine requirements the first two hours postoperative Ketogan requirements 2-24 hours postoperative Sedation scores 0,2,4,6,8 and 24 hours postoperative Nausea scores 0,2,4,6,8 and 24 hours postoperative Number of vomits 0-2,2-4,4-6,6-8 and 8-24 hours postoperative | — |
Countries
Denmark
Outcome results
None listed