E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002708 |
E.1.2 | Term | Anterior thoracotomy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036372 |
E.1.2 | Term | Postero-lateral thoracotomy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043491 |
E.1.2 | Term | Thoracotomy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067831 |
E.1.2 | Term | Post-thoracotomy pain syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043491 |
E.1.2 | Term | Thoracotomy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067831 |
E.1.2 | Term | Post-thoracotomy pain syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
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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 investigate the effect of gabapentin on thoracale epidural analgesia after thoracotomi, including assessment and analgesia, pain intensity, pain quality, and whether gabapentin prevents the development of chronic pain conditions.
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of gabapentin on convalescence of various body functions, potential reduction in morbidity as well as hospital length of stay, patient satisfaction and patient reported quality of life, cost and side effects, and to assess whether a potential opioid sparring effect has importance for patient safety. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients scheduled to undergo elective lung resection via thoracotomy on a malignant indication at the Department of Cardithoracic and Vascular Surgery, Aarhus University Hospital, Skejby.
2. Age > 18 and < 80 years
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E.4 | Principal exclusion criteria |
• Inability to answer the detailed questionnaire on pain and quality of life • Psychiatric disease (ICD-10) • Severe renal impairment (se-creatinin > 110 mmol/l) • Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen • Standard use of opiod analgesics • Treatment with anticonvulsants or tricyclic antidepressants • Use of antacids 24 hours before the intake of study medication • Contraindicated placement of a thoracic epidural catheter • Previous ipsilateral thoracotomy • Presence of a chronic pain syndrome • Acute pancreatitis • A history of past or current alcohol and / or ilegal substance abuse. Using the Danish National Board of Health's recommendations for weekly intake of < 14 drinks/units for women and < 21 drinks/units for men and / or former or current abuse of drugs. • A history of gastric or duodenal ulcer • Gastrointestinal obstruction • Pregnancy • Participation in another intervention study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints:
1) Pain, NRS-score 2) Morphine consumption
Secondary endpoints:
1) Mobility (6 minutes walking test) 2) Lung function (spirometry) 3) Side effects 3) Hospital stay 4) Health related quality of life 5) Patient satisfaction
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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 | 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) | 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 | 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.8.3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 receipt of the last follow up questionnaire responded by the last participant in the IMP-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 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |