- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701921
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Thessaly
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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:
|
Active Comparator: Pregabalin 150
Pregabalin 150mg by mouth one hour before surgery
|
pregabalin 150mg by mouth one hour before surgery
Other Names:
|
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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 7/13-07-2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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