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The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aikaterini Bouzia, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01701921
First received: October 3, 2012
Last updated: September 8, 2016
Last verified: September 2016

October 3, 2012
September 8, 2016
July 2011
February 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01701921 on ClinicalTrials.gov Archive Site
Remaining surgery related pain and analgesics consumption [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
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
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
Not Provided
Not Provided
 
The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Pain
  • Drug: Pregabalin 75mg
    Pregabalin 75mg by mouth one hour before surgery
    Other Name: Lyrica
  • Drug: pregabalin 150 mg
    pregabalin 150mg by mouth one hour before surgery
    Other Name: Lyrica
  • Drug: Placebo
    Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
    Other Name: Sugar pill
  • Experimental: Pregabalin 75
    Pregabalin 75mg by mouth one hour before surgery
    Intervention: Drug: Pregabalin 75mg
  • Active Comparator: Pregabalin 150
    Pregabalin 150mg by mouth one hour before surgery
    Intervention: Drug: pregabalin 150 mg
  • Placebo Comparator: Sugar pill
    Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
June 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01701921
7/13-07-2011
No
Undecided
Not Provided
Aikaterini Bouzia, Larissa University Hospital
Larissa University Hospital
Not Provided
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
Larissa University Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP