Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Gabapentin group (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Aarhus University Hospital Official(s) and/or principal investigator(s):
Vibeke Hjortdal, MD, Dr.sci, Principal Investigator, Affiliation: Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
Overall contact:
Imran Parvaiz, MD, Phone: +45 40547377, Email: imran@dadlnet.dk
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.
Clinical Details
Official title: Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: PainMorphine consumption
Secondary outcome: PONVMedication side effects Hospital stay VAS score and medication 30 days after the operation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients scheduled for elective cardiac surgery with median sternotomy at the
department of cardiac surgery, Aarhus University Hospital, Skejby.
2. Patients older than 18 years.
Exclusion Criteria:
1. Patients unable to cooperate.
2. Known allergy for Gabapentin or opioids.
3. Acute pancreatitis
4. History of gastric or peptic ulcer.
5. History of alcohol or drug abuse.
6. Chronic pain or daily intake of analgesics or corticosteroids.
7. Gastrointestinal obstruction
8. Impaired liver function.
9. Impaired kidney function.
10. Previous operation with median sternotomy
11. Pregnant women
Locations and Contacts
Imran Parvaiz, MD, Phone: +45 40547377, Email: imran@dadlnet.dk
Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby, Aarhus 8200, Denmark; Not yet recruiting
Imran Parvaiz, MD, Phone: +45 40547377, Email: imran@dadlnet.dk
Mariann T Jensen, MD, Email: MTZ@sks.aaa.dk
Vibeke Hjortdal, MD, Dr.Sci, Principal Investigator
Imran Parvaiz, MD, Sub-Investigator
Mariann T Jensen, MD, Sub-Investigator
Cardiothoracic and vascular department, Skejby Sygehus, Aarhus, Denmark; Recruiting
Mariann Tang Jensen, MD
Additional Information
Starting date: January 2008
Ending date: February 2009
Last updated: February 12, 2009
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