Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

November 9, 2012 updated by: Sidiropoulou Tatiana, Attikon Hospital
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Attikon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pregabalin
perioperative pregabalin starting the evening before surgery, and for five days postoperatively
Drug: Pregabalin and normal saline infusion, PRG
Active Comparator: pregabalin and continuous wound infusion
Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter
Drug: Pregabalin and ropivacaine 02% infusion
Placebo Comparator: placebo
Placebo drug and normal saline infusion
Drug: Placebo drug, normal saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain control
Time Frame: 5 days postoperatively
5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
morphine consumption
Time Frame: 3 days postoperatively
3 days postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
side effects, pain at 1 and 3 months, incidence of neuropathic pain
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Investigators

  • Principal Investigator: Tatiana Sidiropoulou, Attikon Hospital
  • Principal Investigator: Eyaggelos Giavasopoulos, Attikon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRGCWI1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-thoracotomy Pain

Clinical Trials on Pregabalin and normal saline infusion, PRG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe