E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Poor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials. |
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E.1.1.1 | Medical condition in easily understood language |
Pain therapy after cesarean delivery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
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 |
The objective of the trial is to evaluate the efficacy of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery by comparing it with a continuous placebo wound infusion.
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the effect of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery on pain intensity, on the incidence of opioids related adverse effects (post-operative nausea and vomiting, pruritus) and the time of first ambulation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria will be all patients undergoing cesarean delivery with - a gestation of 34 weeks or more - American Society of Anesthesiology (ASA) I or II - ≥ age 18 years - signed informed consent |
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E.4 | Principal exclusion criteria |
Exclusion criteria will be - allergies to used analgesics - ASA III or higher - pre- or eclampsia - diabetes mellitus type I or II - postpartum hemorrhage (defined as ≥ 1 L blood loss) - BMI ≥ 35 - preoperative opioid consumption/abuse - psychiatric disorders - patient refusal to participate - language barrier |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be the total amount of opioid use, measured on the PCA device, in the first 48 hours after cesarean delivery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoint 0 hours: start of cesarean section defined as time of skin incision. Timepoint 48 hours: period of 48 hours after surgery in which opioids use by PCA will be recorded. |
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E.5.2 | Secondary end point(s) |
The secondary outcomes will be the intensity of pain, the incidence of adverse effects (post-operative nausea and vomiting, pruritus) and time of first ambulation. Pain will be evaluated by visual analog scale (VAS) (0-10) at rest and at mobilization (defined as pain during coughing) 2 hours, 6 hours, 12 hours and 24 hours after surgery (except if the patient is asleep) and once daily until discharge thereafter. The VAS tool will consist of a 10-cm horizontal line with at one end no pain and at the other end worst pain ever. Patients will be asking to mark the point on the scale that corresponded to their pain. Post-operative nausea and vomiting and pruritus will be evaluated using a categorical scale ranging from 0 to 2 (0: none, 1: mild (requiring no treatment) and 2: severe (requiring treatment) at the same interval pain will be assessed. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 hours, 6 hours, 12 hours, 24 hours after surgery (except if the patient is asleep) and thereafter once daily until discharge of the patient, his pain and nausea and vomiting will be evaluated. Time of first ambulation after cesarian section will also be noted. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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
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Study ends once the last selected patient is discharged form the maternity. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |