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| Name | Class |
|---|---|
| Aarhus University Hospital Skejby | OTHER |
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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.
The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.
Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.
In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Gabapentin group |
|
| Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg) Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg) Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg) Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent post surgical pain | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain. | 3 months after surgery |
| Acute postoperative pain | Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain. | Within the first 5 postoperative days |
| Usage of epidural infusion of local and opioid analgesics (ml) | Within the first 5 postoperative days | |
| Persistent post surgical pain | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain. | 6 months following surgery |
| Persistent post surgical pain | Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain. | 12 months following surgery |
| Early postoperative pain |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of opioid analgesics | Within the first 5 postoperative days | |
| Time to first request for additional analgesics | Within the first 5 postoperative days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans K Pilegaard, MD, Chief Surgeon | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark | Principal Investigator |
| Kasper Grosen, RN, MHScS, PhDS | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark | Study Director |
| Vibeke Hjortdal, MD, Professor, DMSc, PhD | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark | Study Chair |
| Mogens P Jensen, MD, Chief Physician, PhD | Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark | Study Chair |
| Gerhard Linnemann, MD, Chief Physician | Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark | Study Chair |
| Vibeke Laursen, RN | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark | Study Chair |
| Anette Hoejsgaard, MD | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Placebo | Drug | Preoperatively (2 hours before surgery): 4 placebo capsules Postoperative day 1: 1 placebo capsule x 2 Postoperative day 2: 1 placebo capsule x 3 Postoperative day 3: 1 placebo capsule x 4 Postoperative day 4: 1 placebo capsule x 4 Postoperative day 5: 1 placebo capsule x 4 |
|
Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain. |
| 14 days (+/-3 days) following discharge |
| Analgesia related side-effects |
Evaluation of the presence and/or severity of confusion, hallucinations, nausea, vomiting, usage of antiemetic drugs, urinary retention, sedation, pruitus, headache, respiratory depression, motor blockade and dizziness |
| Within the first 5 postoperative days |
| Convalescence of gastrointestinal function | Convalescence of gastrointestinal function (time to first defecation) | Within the first 5 postoperative days |
| Health related quality of life | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. | Day 14 (+/-3 days) following discharge |
| Patient satisfaction | Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire | Within the first 5 postoperative days |
| Intensity of preoperative anxiety | Anxiety is measured on a 11-point numeric rating scale (NRS). | 2 hours after administration of the first dose of study medication |
| Convalescence of lung function (spirometry) | FVC, FEV-1 and PEF is measured. | Within the first five postoperative days |
| Sleep quality | Sleep quality is measured on a 11-point numeric rating scale (NRS) | Within the first five postoperative days |
| Walking distance (meters) | Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3. | Postoperative day 3 |
| Fatigue | Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe). | Within the first 5 postoperative days |
| Hospital length of stay (days) | At time of discharge |
| Health related quality of life | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. | 3 months following surgery |
| Health related quality of life | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. | 6 months following surgery |
| Health related quality of life | Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires. | 12 months following surgery |
| Use of a vasopressor agent to correct hypotension | Within the first 5 days of surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |