The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Larissa University Hospital
Sponsor:
Information provided by (Responsible Party):
Aikaterini Bouzia, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01701921
First received: October 3, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701921

Contacts
Contact: Georgios Vretzakis, Medicine gvretzakis@yahoo.com
Contact: Konstantinos G Stamoulis, Medicine konstaarist@windowslive.com

Locations
Greece
Univercity Hospital of Larissa Recruiting
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
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
  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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 19, 2014