| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy | ||||||||
| Official Title † | Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment | ||||||||
| Primary Outcome Measure † | Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ] Morphine consumption [ Time Frame: 1 month ] [ Designated as safety issue: No ] |
||||||||
| Secondary Outcome Measure † | PONV [ Time Frame: 1 month ] [ Designated as safety issue: No ] Medication side effects [ Time Frame: 1 month ] [ Designated as safety issue: No ] Hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ] VAS score and medication 30 days after the operation [ Time Frame: 1 month ] [ Designated as safety issue: No ] |
||||||||
| Condition † | Pain, Postoperative | ||||||||
| Intervention † | Drug: Gabapentin group | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 64 | ||||||||
| Start Date † | January 2008 | ||||||||
| Completion Date | June 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | Denmark | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00572208 | ||||||||
| Organization ID | Gabapentin01 | ||||||||
| Secondary IDs †† | 2007-001479-12 | ||||||||
| Study Sponsor † | Aarhus University Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | University of Aarhus | ||||||||
| Verification Date | December 2007 | ||||||||
| First Received Date † | December 11, 2007 | ||||||||
| Last Updated Date | December 11, 2007 | ||||||||
|
