E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic gallstone disease |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018109 |
E.1.2 | Term | Generalized convulsive epilepsy |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007647 |
E.1.2 | Term | Cardiovascular collapse |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002199 |
E.1.2 | Term | Anaphylactic shock |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy |
|
E.2.2 | Secondary objectives of the trial |
- 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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18-75 years with an ASA I or II classification who undergo elective laparoscopic cholecystectomy for symptomatic gallstone disease |
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
When the last subject of the n =74 is included, underwent a laparoscopic cholecystectomy and his/her postoperative pain score is obtained. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |