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

Primary Purpose

Chronic Pain

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain focused on measuring thoracotomy, chronic, pain, pregabalin, Lyrica

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Jorge E Zamora

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo capsules

pregabalin capsules

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of chronic post thoracotomy pain syndrome

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

Full Information

First Posted
October 20, 2009
Last Updated
April 10, 2012
Sponsor
Queen's University
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00998816
Brief Title
The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
thoracotomy, chronic, pain, pregabalin, Lyrica

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
pregabalin capsules
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of chronic post thoracotomy pain syndrome
Time Frame
6 months following surgery
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E Zamora, MD
Organizational Affiliation
Queen's University/ Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Jorge E Zamora
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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