E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative shoulder pain, after lobectomy and pneumonectomy |
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E.1.1.1 | Medical condition in easily understood language |
Shoulder pain after major lung operations |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
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 |
To test whether blockade of the phrenic nerve can reduce postoperative shoulder pain after lobectomy and pneumonectomy.
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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 |
1. Patients planned for elective lobectomy or pneumonectomy.
2. 18 years or more on the day of the operation.
3. Danish skills appropriate for fulfilling preoperative questionnaires. |
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E.4 | Principal exclusion criteria |
1. Known contralateral paresis of the Phrenic nerve.
2. Allergy to Ropivacaine or NaCl.
3. Preoperative ipsilateral shoulder pain.
4. Infection or eckzema on the ipsilateral neck. Clinical decision.
5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation.
6. Pregnancy.
7. Acute porphyria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with shoulder pain within 6 hours after the operation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Retrospektive NRS, 6 hours after the operation. |
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E.5.2 | Secondary end point(s) |
1. Number of patients with shoulder pain within the first 3 postoperative days.
2. NRS for shoulder pain in the first 3 postoperative days.
3. NRS for overall pain in the first 3 postoperative days
4. Opioid us in the first 3 postoperative days .
5. Time on the recovery room.
6. Shoulder pain after 3 months.
7. NRS for sholder pain after 3 months.
8. Thoracic pain after 3 months.
9. NRS for thoracic pain after 3 months.
10. Opioid use after 3 months.
11. Shoulderfunction after 3 months. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 3 days after the operation.
2. Retrospective NRS 3 times a day, day 0-3 after the operation.
3. Retrospective NRS 3 times a day, day 0-3 after the operation.
4. Cumulated opiod use, day 0-3 after the operation.
5. Time at discharge from the recovery room.
6. 3 months after the operation.
7. 3 months after the operation.
8. 3 months after the operation.
9. 3 months after the operation.
10. 3 months after the operation.
11. 3 months after the operation. |
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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 | 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 | 1 |
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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The patients are followed up per letter after 3 months.
When every patient has been followed up, the trial has ended. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |