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The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701921
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : September 12, 2016
Information provided by (Responsible Party):
Aikaterini Bouzia, Larissa University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Pregabalin 75mg Drug: pregabalin 150 mg Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery
Study Start Date : July 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin 75
Pregabalin 75mg by mouth one hour before surgery
Drug: Pregabalin 75mg
Pregabalin 75mg by mouth one hour before surgery
Other Name: Lyrica

Active Comparator: Pregabalin 150
Pregabalin 150mg by mouth one hour before surgery
Drug: pregabalin 150 mg
pregabalin 150mg by mouth one hour before surgery
Other Name: Lyrica

Placebo Comparator: Sugar pill
Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery
Drug: Placebo
Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
Other Name: Sugar pill

Primary Outcome Measures :
  1. opioid consumption and other analgesics after surgery [ Time Frame: 24 hours after surgery ]
    Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.

Secondary Outcome Measures :
  1. Remaining surgery related pain and analgesics consumption [ Time Frame: 3 months after surgery ]
    Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701921

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Univercity Hospital of Larissa
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
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Principal Investigator: Aikaterini A Bouzia, Medicine PhD candidate, School of Medicine, Univercity of Larissa
Study Director: Georgios Vretzakis, Medicine Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
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Responsible Party: Aikaterini Bouzia, MD, Larissa University Hospital Identifier: NCT01701921    
Other Study ID Numbers: 7/13-07-2011
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Aikaterini Bouzia, Larissa University Hospital:
cardiac surgery
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs