NCT01701921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2 postoperative-pain

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

4.6 years

First QC Date

October 3, 2012

Last Update Submit

September 8, 2016

Conditions

Postoperative Pain

Keywords

cardiac surgerypregabalinpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • opioid consumption and other analgesics 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 Outcomes (1)

  • Remaining surgery related pain and analgesics consumption

    3 months after surgery

Study Arms (3)

Pregabalin 75

EXPERIMENTAL

Pregabalin 75mg by mouth one hour before surgery

Drug: Pregabalin 75mg

Pregabalin 150

ACTIVE COMPARATOR

Pregabalin 150mg by mouth one hour before surgery

Drug: pregabalin 150 mg

Sugar pill

PLACEBO COMPARATOR

Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery

Drug: Placebo

Interventions

Pregabalin 75mgDRUG

Pregabalin 75mg by mouth one hour before surgery

Also known as: Lyrica
Pregabalin 75
pregabalin 150 mgDRUG

pregabalin 150mg by mouth one hour before surgery

Also known as: Lyrica
Pregabalin 150
PlaceboDRUG

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

Also known as: Sugar pill
Sugar pill

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' age 18-85years who are undergoing cardiac surgery

You may not qualify if:

  • Chronic pain syndromes
  • Renal failure
  • Age \>85
  • Allergy to Pregabalin
  • Patients already taking pregabalin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univercity Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PregabalinSugars

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Aikaterini A Bouzia, Medicine

    PhD candidate, School of Medicine, Univercity of Larissa

    PRINCIPAL INVESTIGATOR

  • Georgios Vretzakis, Medicine

    Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

July 1, 2011

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

GR(1)