The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
Information source: Larissa University Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Pregabalin 75mg (Drug); pregabalin 150 mg (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Larissa University Hospital Official(s) and/or principal investigator(s):
Aikaterini A Bouzia, Medicine, Principal Investigator, Affiliation: PhD candidate, School of Medicine, Univercity of Larissa
Georgios Vretzakis, Medicine, Study Director, Affiliation: Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
Overall contact:
Georgios Vretzakis, Medicine, Email: gvretzakis@yahoo.com
Summary
The purpose of this study is to determine whether pregabalin is effective in the treatment
of acute postoperative pain after cardiac surgery if administered before the surgery.
Clinical Details
Official title: The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: opioid consumption and other analgesics after surgery
Secondary outcome: Remaining surgery related pain and analgesics consumption
Detailed description:
Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and
anxiolytic properties and was also used to treat neuropathic pain. In recent years it has
been used as part of a multimodal management of acute postoperative pain after various types
of surgery. We study the effect of pregabalin administered before cardiac surgery on acute
and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various
analgesic methods have been used from time to time (opioids, regional analgesia,
non-steroidal anti-inflammatory drugs). In our research patients will be divided into three
groups. The control group will receive a placebo capsule before surgery. The second group
will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of
pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine
pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale
(0-10) every day. Total morphine consumption by the patients as well as any other pain
medications administered supplementary will be registered and compared between the different
groups. Remaining postoperative pain will be assessed after 3 months. The results will be
statistically analyzed in order to determine whether there is significant difference in pain
management between the groups.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients' age 18-85years who are undergoing cardiac surgery
Exclusion Criteria:
- Chronic pain syndromes
- Renal failure
- Age >85
- Allergy to Pregabalin
- Patients already taking pregabalin
Locations and Contacts
Georgios Vretzakis, Medicine, Email: gvretzakis@yahoo.com
Univercity Hospital of Larissa, Larissa, Thessaly 41110, Greece; Recruiting
Additional Information
Starting date: July 2011
Last updated: October 3, 2012
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