E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
In endometriosis, cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grow outside of it. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014778 |
E.1.2 | Term | Endometriosis |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption
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E.2.2 | Secondary objectives of the trial |
To examine analgesic efficacy of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital will be included in the study. |
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E.4 | Principal exclusion criteria |
• Age < 18 years • American Society of Anesthesiologists (ASA) physical status IV or V • Allergy to clonidine • Inability to provide informed consent • Known severe renal insufficiency • Known severe bradyarrhythmia • Pregnancy, lactation • Daily opioid consumption the last 7 days before surgery • Pain intensity >5 on more than half of the days during the last month |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is postoperative opioid consumption |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 hours after arrival at the PACU |
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E.5.2 | Secondary end point(s) |
• Postoperative opioid consumption • Intensity of pain at rest and during coughing • Shivering • Sedation • Nausea and/or vomiting • Time for discharge from the PACU |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Postoperative opioid consumption within the first 6 hours after arrival at the PACU (or at hospital discharge if sooner than 6 hours) (mean cumulative iv. morphine equivalents in mg) • Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10) • Shivering at 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsay Sedation Score 1-6) • Nausea and/or vomiting 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Time for discharge from the PACU |
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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 | 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) | 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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |