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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

This study is not yet open for participant recruitment.
Verified by University of Aarhus, December 2007

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
Pain, Postoperative
Drug: Gabapentin group

MedlinePlus related topics:   Nausea and Vomiting   

ChemIDplus related topics:   Gabapentin   

U.S. FDA Resources

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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Morphine consumption [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   64
Study Start Date:   January 2008
Estimated Study Completion Date:   June 2008

Arms Assigned Interventions
1: Active Comparator
Gabapentin group
Drug: Gabapentin group

Gabapentin group:

Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)

  1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
2: No Intervention
placebo

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572208

Contacts
Contact: Imran Parvaiz, MD     +45 40547377     imran@dadlnet.dk    
Contact: Mariann T Jensen, MD     MTZ@sks.aaa.dk    

Locations
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            

Sponsors and Collaborators
Aarhus University Hospital

Investigators
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

Study placed in the following topic categories:
Excitatory Amino Acids
Signs and Symptoms
Postoperative Complications
Gabapentin
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 10, 2008




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