Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
Information source: Centre hospitalier de l'Université de Montréal (CHUM)
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Condition(s) targeted: Neuropathic Pain
Intervention: Pregabalin (Drug); Placebo (Drug)
Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM)
Official(s) and/or principal investigator(s):
FranÃ§ois Girard, MD, Principal Investigator, Affiliation: Centre Hospitalier de l'UniversitÃ© de MontrÃ©al
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.
Official title: Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Development of neuropathic pain and intensity of pain assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale and Brief Pain Inventory questionnaire (BPI).
Secondary outcome: Intensity of postoperative pain using a Visual Numeric Pain Scale (VNPS).
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.
One hundred and twenty patients will be divided in two equal groups (to receive pregabalin
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
- The type of pain, with specific attention to identifying the presence of neuropathic
- 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.
Minimum age: 18 Years.
Maximum age: 80 Years.
- Patients aged 18 to 80 years.
- Patients who are to undergo an elective thoracotomy in the lateral decubitus
- Patients who are ASA I to III inclusive.
- 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
Locations and Contacts
Centre Hospitalier de l'UniversitÃ© de MontrÃ©al (HÃ´pital Notre-Dame), Montreal, Quebec H2L 4M1, Canada
Starting date: June 2010
Last updated: April 11, 2012