Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

NCT ID: NCT01726205

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Detailed Description

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Conditions

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Post-thoracotomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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pregabalin

perioperative pregabalin starting the evening before surgery, and for five days postoperatively

Group Type ACTIVE_COMPARATOR

Pregabalin and normal saline infusion, PRG

Intervention Type DRUG

pregabalin and continuous wound infusion

Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter

Group Type ACTIVE_COMPARATOR

Pregabalin and ropivacaine 02% infusion

Intervention Type DRUG

placebo

Placebo drug and normal saline infusion

Group Type PLACEBO_COMPARATOR

Placebo drug, normal saline infusion

Intervention Type DRUG

Interventions

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Pregabalin and normal saline infusion, PRG

Intervention Type DRUG

Pregabalin and ropivacaine 02% infusion

Intervention Type DRUG

Placebo drug, normal saline infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for a thoracotomy,

Exclusion Criteria

* age \>70 years
* BMI \> 30
* preoperative Hb \< 10 mg/dL
* preexistent chronic pain
* neurologic disease
* chronic assumption of alcohol
* treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sidiropoulou Tatiana

Lecturer in Anesthesiology, University of Athens

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatiana Sidiropoulou

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Eyaggelos Giavasopoulos

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Locations

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Attikon Hospital

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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PRGCWI1

Identifier Type: -

Identifier Source: org_study_id