The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Jorge Zamora, Queen's University
ClinicalTrials.gov Identifier:
NCT00998816
First received: October 20, 2009
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).


Condition Intervention Phase
Chronic Pain
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Incidence of chronic post thoracotomy pain syndrome [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function [ Time Frame: During hospital stay and at 2, 4, and 6 months postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo capsules
one placebo capsule will be administered 1 hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12h BID for 10 days following lateral thoracotomy.
Drug: Pregabalin
pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.
Other Names:
  • Pregabalin
  • Lyrica
Active Comparator: pregabalin capsules
Pregabalin capsules (150mg) will be administered one hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12 hours (BID) for 10 days following lateral thoracotomy.
Drug: Pregabalin
pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.
Other Names:
  • Pregabalin
  • Lyrica

Detailed Description:

A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III

Exclusion Criteria:

  • Inability ot adhere to study protocol:

    • intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement
    • inability to respond to the study questionnaire
    • renal insufficiency(serum creatinine > 1.5 upper limit of normal)
    • Body Mass index > 40
    • planned post-operative ventilation.
  • Confounding procedural factors which might affect validity of data:

    • previous ipsilateral thoracotomy
    • surgery for tumor extending into the chest wall
    • rest pain in proposed surgical area pre-operatively
    • chest tube in situ at time of surgery
    • requirement for second thoracotomy or re-occurrence of disease after surgery *isolated pleuroscopy or pleurodesis procedures.
  • Potential interaction with study medications and patient's current medications:

    • current alcohol or other substance abuse
    • chronic steroid use
    • pre-existing chronic pain requiring chronic analgesic use
    • history of seizure disorder requiring treatment with an anticonvulsant
    • current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)
    • history of congestive heart failure
    • major psychiatric disorder
    • any contraindication to use of NSAIDs.
  • Insufficient safety data in the patient population:

    • patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding
    • weight <50 Kg
    • dizziness while inpatient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998816

Locations
Canada, Ontario
Dr. Jorge E Zamora
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
McMaster University
Investigators
Principal Investigator: Jorge E Zamora, MD Queen's University/ Kingston General Hospital
  More Information

No publications provided

Responsible Party: Jorge Zamora, Associate Professor, MD, FRCPC, Queen's University
ClinicalTrials.gov Identifier: NCT00998816     History of Changes
Other Study ID Numbers: ANAE 153-09
Study First Received: October 20, 2009
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Queen's University:
thoracotomy
chronic
pain
pregabalin
Lyrica

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014