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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001479-12 |
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In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.
The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.
Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.
We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gabapentin group |
|
| 2 | No Intervention | placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin group | Drug | Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 1 month | |
| Morphine consumption | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| PONV | 1 month | |
| Medication side effects | 1 month | |
| Hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imran Parvaiz, MD | Contact | +45 40547377 | imran@dadlnet.dk | |
| Mariann T Jensen, MD | Contact | MTZ@sks.aaa.dk |
| Name | Affiliation | Role |
|---|---|---|
| Vibeke Hjortdal, MD, Dr.sci | Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby | Not yet recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| 1 month |
| VAS score and medication 30 days after the operation | 1 month |
| Cardiothoracic and vascular department, Skejby Sygehus | Recruiting | Aarhus | Denmark |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |