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Completed

NCT Number: NCT01701921

The Effects of Pregabalin on 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Univercity Hospital of Larissa

Larissa, Thessaly, 41110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 75mg

Drug

Pregabalin 75mg by mouth one hour before surgery

Other names: Lyrica

Pregabalin 150 mg

Drug

pregabalin 150mg by mouth one hour before surgery

Other names: Lyrica

Placebo

Drug

Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery

Other names: Sugar pill

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2012
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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