The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
Chronic Pain
About this trial
This is an interventional prevention trial for Chronic Pain focused on measuring thoracotomy, chronic, pain, pregabalin, Lyrica
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.
Sites / Locations
- Dr. Jorge E Zamora
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo capsules
pregabalin 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.
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.