NCT01701921

The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Larissa University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Pregabalin 75mg	Pregabalin 75mg by mouth one hour before surgery
DRUG	pregabalin 150 mg	pregabalin 150mg by mouth one hour before surgery
DRUG	Placebo	Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2012-10-05
• Last updated: 2016-09-12

Locations

1 site across 1 country: Greece