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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Pregabalin

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No