The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Larissa University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: pregabalin 150 mg; Drug: Pregabalin 75mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01701921

7/13-07-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 3 patient groups, including a placebo group

Pregabalin 75

Experimental group

Description:

Pregabalin 75mg by mouth one hour before surgery

Treatment:

Drug: Pregabalin 75mg

Pregabalin 150

Active Comparator group

Description:

Pregabalin 150mg by mouth one hour before surgery

Treatment:

Drug: pregabalin 150 mg

Sugar pill

Placebo Comparator group

Description:

Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery

Treatment:

Drug: Placebo