The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

NCT ID: NCT01701921

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin 75

Pregabalin 75mg by mouth one hour before surgery

Group Type: EXPERIMENTAL

Pregabalin 75mg

Intervention Type: DRUG

Pregabalin 75mg by mouth one hour before surgery

Pregabalin 150

Pregabalin 150mg by mouth one hour before surgery

Group Type: ACTIVE_COMPARATOR

pregabalin 150 mg

Intervention Type: DRUG

pregabalin 150mg by mouth one hour before surgery

Sugar pill

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery

Interventions

Pregabalin 75mg

Pregabalin 75mg by mouth one hour before surgery

Intervention Type: DRUG

pregabalin 150 mg

pregabalin 150mg by mouth one hour before surgery

Intervention Type: DRUG

Placebo

Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery

Intervention Type: DRUG

Other Intervention Names

Lyrica; Lyrica; Sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Larissa University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aikaterini Bouzia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aikaterini A Bouzia, Medicine

Role: PRINCIPAL_INVESTIGATOR

PhD candidate, School of Medicine, Univercity of Larissa

Georgios Vretzakis, Medicine

Role: STUDY_DIRECTOR

Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa

Locations

Univercity Hospital of Larissa

Larissa, Thessaly, Greece

Countries

Greece

Other Identifiers

7/13-07-2011

Identifier Type: -

Identifier Source: org_study_id