Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy|
- Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Morphine consumption [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||February 2009|
|Estimated Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Drug: Gabapentin group
Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
No Intervention: 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572208
|Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby|
|Aarhus, Denmark, 8200|
|Cardiothoracic and vascular department, Skejby Sygehus|
|Principal Investigator:||Vibeke Hjortdal, MD, Dr.sci||Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby|