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Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidiropoulou Tatiana, Attikon Hospital
ClinicalTrials.gov Identifier:
NCT01726205
First received: November 9, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Attikon Hospital:

Primary Outcome Measures:
  • Pain control [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morphine consumption [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • side effects, pain at 1 and 3 months, incidence of neuropathic pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sidiropoulou Tatiana, Lecturer in Anesthesiology, University of Athens, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01726205     History of Changes
Other Study ID Numbers: PRGCWI1
Study First Received: November 9, 2012
Last Updated: November 9, 2012
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Ropivacaine
Pregabalin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013