The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

September 8, 2016 updated by: Aikaterini Bouzia, Larissa University Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Univercity Hospital of Larissa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin 75
Pregabalin 75mg by mouth one hour before surgery
Pregabalin 75mg by mouth one hour before surgery
Other Names:
  • Lyrica
Active Comparator: Pregabalin 150
Pregabalin 150mg by mouth one hour before surgery
pregabalin 150mg by mouth one hour before surgery
Other Names:
  • Lyrica
Placebo Comparator: Sugar pill
Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery
Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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