Back to results

The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Pregabalin 75mg

pregabalin 150 mg

Placebo

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring cardiac surgery, pregabalin, postoperative pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Univercity Hospital of Larissa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Pregabalin 75

Pregabalin 150

Sugar pill

Arm Description

Pregabalin 75mg by mouth one hour before surgery

Pregabalin 150mg by mouth one hour before surgery

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Remaining surgery related pain and analgesics consumption

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

Full Information

NCT ID

NCT01701921

First Posted

October 3, 2012

Last Updated

September 8, 2016

Sponsor

Larissa University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01701921

Brief Title

The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Larissa University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

cardiac surgery, pregabalin, postoperative pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin 75

Arm Type

Experimental

Arm Description

Pregabalin 75mg by mouth one hour before surgery

Arm Title

Pregabalin 150

Arm Type

Active Comparator

Arm Description

Pregabalin 150mg by mouth one hour before surgery

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pregabalin 75mg

Other Intervention Name(s)

Lyrica

Intervention Description

Pregabalin 75mg by mouth one hour before surgery

Intervention Type

Drug

Intervention Name(s)

pregabalin 150 mg

Other Intervention Name(s)

Lyrica

Intervention Description

pregabalin 150mg by mouth one hour before surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

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

Primary Outcome Measure Information:

Title

opioid consumption and other analgesics after surgery

Description

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.

Time Frame

24 hours after surgery

Secondary Outcome Measure Information:

Title

Remaining surgery related pain and analgesics consumption

Description

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

Time Frame

3 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aikaterini A Bouzia, Medicine

Organizational Affiliation

PhD candidate, School of Medicine, Univercity of Larissa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Georgios Vretzakis, Medicine

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Univercity Hospital of Larissa

City

Larissa

State/Province

Thessaly

ZIP/Postal Code

41110

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

We'll reach out to this number within 24 hrs