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| Sponsored by: |
Aarhus University Hospital |
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00572208 |
Purpose
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 | Intervention |
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Pain, Postoperative |
Drug: Gabapentin group |
| MedlinePlus related topics: | Nausea and Vomiting |
| ChemIDplus related topics: | Gabapentin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Official Title: | Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy |
| Estimated Enrollment: | 64 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
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1: Active Comparator
Gabapentin group
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Drug: Gabapentin group
Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
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2: No Intervention
placebo
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Imran Parvaiz, MD | +45 40547377 | imran@dadlnet.dk |
| Contact: Mariann T Jensen, MD | MTZ@sks.aaa.dk |
| Denmark | |||||
| Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby | Not yet recruiting | ||||
| Aarhus, Denmark, 8200 | |||||
| Contact: Imran Parvaiz, MD +45 40547377 imran@dadlnet.dk | |||||
| 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 | |||||
| Aarhus University Hospital |
| Principal Investigator: | Vibeke Hjortdal, MD, Dr.sci | Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby |
More Information
| Responsible Party: | Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby ( Vibeke Hjortdal, Professor, Consultant, Dr. Sci., PhD. ) |
| Study ID Numbers: | Gabapentin01, 2007-001479-12 |
| First Received: | December 11, 2007 |
| Last Updated: | December 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00572208 |
| Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency |
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