E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain |
Postoperatieve pijn |
|
E.1.1.1 | Medical condition in easily understood language |
Pain after surgery |
Pijn na een operatie |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
|
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 evaluate the postoperative opioid consumption and pain after laparoscopic bariatric surgery. Our hypothesis is that less opioids will be consumed by patients in the group receiving local anesthetics compared to normal saline. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate side-effects from opioids, mobilisation, length of hospitalstay and patientsatisfaction with pain treatment. Our hypothosis is that in our treatment group we will less side-effect from opioids. We expect to see that mobilisation within two hours after surgery will be possible for more patients in our treatment group, length of hospitalstay will be shorter and patientsatisfaction with pain treatment will improve. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients > 18 years old
- Planned primary laparoscopic gastric bypass surgery
- BMI > 35 |
|
E.4 | Principal exclusion criteria |
- No informed consent possible or obtained
- Bariatric surgery or major abdominal surgeries in the past
- Known side effects or allergies to morfine or bupivacaine
- Use of opioids or benzodiazepines in the past 3 months
- History of alcohol- or drugabuse
- Indication for premedication with a benzodiazepine |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Directly after surgery at 10, 20 and 30minutes after arrival at the recovery room.
At 6, 12, 18 and 24 hours after surgery. |
|
E.5.2 | Secondary end point(s) |
Side effects
Hospital stay
Mobilisation within 2 hours yes or no
Patientsatisfaction |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Side effects:
Directly after surgery at 10, 20 and 30minutes after arrival at the recovery room.
At 6, 12, 18 and 24 hours after surgery.
Mobilisation: 2 hours after surgery
Patientsatisfaction: 24 hours after surgery
Hospitalstay: a few days after surgery, depending on when the patient leaves the hospital |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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
|
The trial is ended after the last patient leaves the hospital. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |