Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

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 Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Gabapentin group

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Parvaiz, MD; Phone Number: +45 40547377; Email: imran@dadlnet.dk
• Study Contact Backup: Name: Mariann T Jensen, MD; Email: MTZ@sks.aaa.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Not yet recruiting
    • Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
    • Contact: Imran Parvaiz, MD; Phone Number: +45 40547377; Email: imran@dadlnet.dk
    • Contact: Mariann T Jensen, MD; Email: MTZ@sks.aaa.dk
    • Principal Investigator: Vibeke Hjortdal, MD, Dr.Sci
    • Sub-Investigator: Imran Parvaiz, MD
    • Sub-Investigator: Mariann T Jensen, MD
  • Aarhus, Denmark
    • Recruiting
    • Cardiothoracic and vascular department, Skejby Sygehus
    • Contact: Mariann Tang Jensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Gabapentin group	Drug: Gabapentin group; Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded); st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded); nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded); rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded); th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded); th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
No Intervention: 2; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain	1 month
Morphine consumption	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
PONV	1 month
Medication side effects	1 month
Hospital stay	1 month
VAS score and medication 30 days after the operation	1 month

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Vibeke Hjortdal, MD, Dr.sci, Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: December 11, 2007
• First Submitted That Met QC Criteria: December 11, 2007
• First Posted (Estimate): December 12, 2007

Study Record Updates

• Last Update Posted (Estimate): February 13, 2009
• Last Update Submitted That Met QC Criteria: February 12, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: Gabapentin01; 2007-001479-12