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This study has been withdrawn prior to enrollment.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

October 20, 2009
April 10, 2012
May 2012
August 2014   (final data collection date for primary outcome measure)
Incidence of chronic post thoracotomy pain syndrome [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998816 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Chronic Pain
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
  • 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.
    Intervention: Drug: Pregabalin
  • 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.
    Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00998816
ANAE 153-09
No
Jorge Zamora, Queen's University
Queen's University
McMaster University
Principal Investigator: Jorge E Zamora, MD Queen's University/ Kingston General Hospital
Queen's University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP