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Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726205
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidiropoulou Tatiana, Attikon Hospital
  Purpose
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Condition Intervention Phase
Post-thoracotomy Pain Drug: Pregabalin and normal saline infusion, PRG Drug: Pregabalin and ropivacaine 02% infusion Drug: Placebo drug, normal saline infusion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sidiropoulou Tatiana, Attikon Hospital:

Primary Outcome Measures:
  • Pain control [ Time Frame: 5 days postoperatively ]

Secondary Outcome Measures:
  • morphine consumption [ Time Frame: 3 days postoperatively ]

Other Outcome Measures:
  • side effects, pain at 1 and 3 months, incidence of neuropathic pain [ Time Frame: 3 months ]

Enrollment: 45
Study Start Date: October 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726205


Locations
Greece
Attikon Hospital
Athens, Greece
Sponsors and Collaborators
Attikon Hospital
Investigators
Principal Investigator: Tatiana Sidiropoulou Attikon Hospital
Principal Investigator: Eyaggelos Giavasopoulos Attikon Hospital
  More Information

Responsible Party: Sidiropoulou Tatiana, Lecturer in Anesthesiology, University of Athens, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01726205     History of Changes
Other Study ID Numbers: PRGCWI1
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Ropivacaine
Pregabalin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs