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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

NCT00572208 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2009-02-13

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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)

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Vibeke Hjortdal, MD, Dr.sci · Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572208 on ClinicalTrials.gov