NCT00998816

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Typical duration for phase_3 chronic-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

October 20, 2009

Last Update Submit

April 10, 2012

Conditions

Chronic Pain

Keywords

thoracotomychronicpainpregabalinLyrica

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic post thoracotomy pain syndrome

    6 months following surgery

Secondary Outcomes (1)

  • 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

    During hospital stay and at 2, 4, and 6 months postoperatively

Study Arms (2)

Placebo capsules

PLACEBO COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

PregabalinDRUG

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.

Also known as: Lyrica
Placebo capsulespregabalin capsules

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jorge E Zamora

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Chronic PainBronchiolitis Obliterans SyndromePain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jorge E Zamora, MD

    Queen's University/ Kingston General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, FRCPC

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

CA(1)