Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT00967135
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2009-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
Study Overview
Official Title:
Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: