E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postoperative analgesia after Caesarean section |
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E.1.1.1 | Medical condition in easily understood language |
Postoperative pain treatment after Caesarean section |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036276 |
E.1.2 | Term | Postoperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 this trial is that the addition of high-dose dexamethasone 25 mg twice (at day 0 and day 1 after surgery) to multimodal analgesia (paracetamol and NSAIDs combined with a single-shot local anesthetic wound infiltration) will result in more effective analgesia and better patient functionality the first 48 hours following Caesarean section compared with a standard 5-mg dose. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Elective (scheduled) caesarean section, term (36 weeks’ gestation or more) pregnancy
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E.4 | Principal exclusion criteria |
Patients are excluded based on following criteria: - ASA classification of physical status 3, 4 and 5 - Patients in labour - Diabetes mellitus, including gestational diabetes - Chronic use of glucocorticoids - Chronic use of opiods - Patients who have received glucocorticoids for fetal lung maturation within the last two weeks - Active peptic ulcer disease or treatment for this condition with the previous three months - Inability to perform evaluation - Age < 18 years - Intolerance or allergy to any of the drugs used in the study - Refusal to sign informed consent - History of chronic pain or substance use disorder
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative pain scores with movement from 4 to 48 hours after caesarean section assessed with area under the NRS score x time curve (AUC).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain scores (NRS score 0 to 10 scale) will be assessed at rest and during mobilization, every hour during the first 4 hours postoperatively. Thereafter, pain scores will be assessed at 6, 12, 18, 24, 36 and 48 hours. |
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E.5.2 | Secondary end point(s) |
- The incidence of postoperative pain, defined as an NRS score of 4 or more during rest and mobilization in the first 48 hours postoperatively - Cumulative pain scores (NRS scores) over 24 and 48 hours at rest. - Use of rescue analgesic - Incidence of PONV and severity of nausea - Blood glucose will be recorded - Patient functional status during the first 48 hours - Patient satisfaction with analgesia: VAS (visual analogue scale, 0-100 mm) score - Fetal and neonatal outcome - Wound healing: assessed during a clinical follow-up 4-6 weeks postoperatively. The obstetrician categorizes wound healing as normal or abnormal. - level of deaxmethasone in breast milk - Length of hospital stay (days)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Pain scores , assessed at rest and during mobilization, every hour for the first 4 hours postoperatively, thereafter at 6, 12, 24, 36 and 48 hours. - The cumulated opioid dose and morphine equivalents every 6-hour interval until 48 hours after delivery will be calculated. Total opioid consumption over 48 hours will be calculated. - Post operative nausea and vomiting willbe recorded for the first 48 hours afer ceasarean section - Blood glucose will be recorded at 7 am on day 1 and day 2 after caesarean section, pre-prandially. - Patient functional status wil be recorded 24 and 48h after caesarean section - Patient satisfaction score will be measures 24 and 48h after caesarean section |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |