Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study is designed to assess:

        1. The impact of taking perioperative pregabalin on the incidence of chronic neuropathic
           pain and postthoracotomy syndrome at 3 months in patients who have undergone a
           thoracotomy with a thoracic epidural as the basic analgesic modality.

        2. The impact of taking perioperative pregabalin on the relief of acute pain, and on the
           use of additional analgesics, such as opioids, for the relief of such pain in patients
           who have undergone thoracic surgery with a thoracic epidural as the basic analgesia.

        3. The impact of taking perioperative pregabalin on the quality of life and level of
           functioning of patients who underwent thoracic surgery 3 months earlier.

        4. The safety profile of pregabalin in this patient population.

      Hypothesis: The basic hypothesis in this study is that a dose of pregabalin administered
      preemptively 1 hour before a thoracotomy, then repeatedly during the postoperative period,
      when neuronal hyperexcitability is at a maximum (i.e., 4 days), will lead to a 33.3% decrease
      in the prevalence of chronic pain 3 months after surgery.
    

Detailed description: 
      Postthoracotomy pain syndrome is a rather frequent phenomenon. Its incidence, as reported in
      the literature, varies but is around 52% at 1 to 2 years after surgery. This syndrome is
      defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar
      at least 2 months after surgery. The pain is very significant, given that 3 to 5% of patients
      report it as being severe, and approximately 50% of patients report limitations in their
      activities of daily living secondary to this pain and consider their pain as their worst
      medical problem. A neuropathic component makes a certain contribution to this pain. Patients
      with this neuropathic component report more-severe pain and take more analgesics. Little is
      known about the origin of this pain, but it seems that the intensity of acute postoperative
      pain is the best predictor of it. Pregabalin could be a possible approach to reducing the
      prevalence of chronic postthoracotomy pain. Its efficacy has been demonstrated in several
      diabetic, postherpetic, incisional and inflammatory neuropathic pain models.

      Methods:

      One hundred and twenty patients will be divided in two equal groups (to receive pregabalin or
      placebo).

      Prior to the induction of general anesthesia, a thoracic epidural will be placed and started
      immediately prior to surgery. The anesthetic technique and monitoring will be standardized.

      During the immediate postoperative period, the intensity of pain will be assessed using a
      VNPS (0-10). Pain will be assessed upon the patient's arrival in and discharge from the
      recovery room and daily thereafter, for a total duration of four postoperative days or until
      discharge from hospital if this occurs before the 4th postoperative day.

      Three months after their surgery, the patients will be contacted by telephone and
      administered a standardized questionnaire for evaluating:

        -  The presence and intensity (based on a VNPS) of pain at the surgical and/or drainage
           tube sites.

        -  The type of pain, with specific attention to identifying the presence of neuropathic
           pain.

        -  The patients' assessment of their quality of life, and the impact, if any, of the pain
           on their level of functioning in their daily lives in relation to their preoperative
           quality of life and functioning.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg oral dose of pregabalin twice daily for 5 consecutive days.; Matching oral placebo twice daily for 5 consecutive days.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thoracotomy; Neuropathic pain