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The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Information source: Larissa University Hospital
ClinicalTrials.gov processed this data on November 27, 2014
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

Page last updated: November 27, 2014

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