The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: Pregabalin 75mg Drug: pregabalin 150 mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery |
- opioid consumption and other analgesics after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]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.
- Remaining surgery related pain and analgesics consumption [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]Patients will be questioned one month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Georgios Vretzakis, Medicine | gvretzakis@yahoo.com | |
| Contact: Konstantinos G Stamoulis, Medicine | konstaarist@windowslive.com |
| Greece | |
| Univercity Hospital of Larissa | Recruiting |
| Larissa, Thessaly, Greece, 41110 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Aikaterini Bouzia, MD, Larissa University Hospital |
| ClinicalTrials.gov Identifier: | NCT01701921 History of Changes |
| Other Study ID Numbers: | 7/13-07-2011 |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Greece: National Organization of Medicine |
Keywords provided by Larissa University Hospital:
|
cardiac surgery pregabalin postoperative pain |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Pregabalin Gamma-Aminobutyric Acid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013