Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Patients aged 18 to 80 years.

• Patients who are to undergo an elective thoracotomy in the lateral decubitus position.

• Patients who are ASA I to III inclusive.

Exclusion Criteria:

• A contraindication to pregabalin.

• A contraindication to the epidural technique.

• The current use of drugs belonging to the class of opioids, NMDA receptor blockers, membrane stabilizing agents (lidocaine mesylates, flecainide) or topical coanalgesics (capsaicin cream, lidocaine patch).

• Previous use of pregabalin or gabapentin.

• Preexisting pain at the site where the surgical incision will be made.

• Presence of a coexisting chronic pain syndrome.

• A creatinine clearance of less than 60 mL/min.

• A previous ipsilateral thoracotomy.

• A recent history of alcohol and/or drug abuse.

• A known allergy to local anesthetics or hydromorphone.

• The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction.