Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00572208
First received: December 11, 2007
Last updated: February 12, 2009
Last verified: February 2009
  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

Study Type: Interventional
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

Resource links provided by NLM:


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: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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)
No Intervention: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 department, Skejby Sygehus Recruiting
Aarhus, Denmark
Contact: Mariann Tang Jensen, MD         
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

No publications provided

Responsible Party: Vibeke Hjortdal, Professor, Consultant, Dr. Sci., PhD., Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier: NCT00572208     History of Changes
Other Study ID Numbers: Gabapentin01, 2007-001479-12
Study First Received: December 11, 2007
Last Updated: February 12, 2009
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on October 22, 2014