Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
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|ClinicalTrials.gov Identifier: NCT00572208|
Recruitment Status : Unknown
Verified February 2009 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : December 12, 2007
Last Update Posted : February 13, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Gabapentin group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||February 2009|
Active Comparator: 1
Drug: Gabapentin group
Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
No Intervention: 2
- Pain [ Time Frame: 1 month ]
- Morphine consumption [ Time Frame: 1 month ]
- PONV [ Time Frame: 1 month ]
- Medication side effects [ Time Frame: 1 month ]
- Hospital stay [ Time Frame: 1 month ]
- VAS score and medication 30 days after the operation [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572208
|Contact: Imran Parvaiz, MD||+45 email@example.com|
|Contact: Mariann T Jensen, MD||MTZ@sks.aaa.dk|
|Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby||Not yet recruiting|
|Aarhus, Denmark, 8200|
|Contact: Imran Parvaiz, MD +45 40547377 firstname.lastname@example.org|
|Contact: Mariann T Jensen, MD MTZ@sks.aaa.dk|
|Principal Investigator: Vibeke Hjortdal, MD, Dr.Sci|
|Sub-Investigator: Imran Parvaiz, MD|
|Sub-Investigator: Mariann T Jensen, MD|
|Cardiothoracic and vascular department, Skejby Sygehus||Recruiting|
|Contact: Mariann Tang Jensen, MD|
|Principal Investigator:||Vibeke Hjortdal, MD, Dr.sci||Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby|