Neuropathic PainNCT00967135
Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
A study testing Pregabalin in people with Neuropathic Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, H2L 4M1
About this study
This study is designed to assess:
- 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.
- 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.
- The impact of taking perioperative pregabalin on the quality of life and level of functioning of patients who underwent thoracic surgery 3 months earlier.
- 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.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Pregabalin, Placebo
- Keywords
- Thoracotomy, Neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
150 mg oral dose of pregabalin twice daily for 5 consecutive days.
PlaceboDrug
Matching oral placebo twice daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Study subjects will be randomized to receive on the morning of surgery, at least 30 minutes before induction, a 150 mg oral dose of pregabalin. Patients will then receive a 150 mg oral dose of pregabalin on the evening of the surgery. Subsequently, patients will receive a 150 mg oral dose of pregabalin twice daily on the following four postoperative days. Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Study subjects will be randomized to receive a matching placebo on the morning of surgery, at least 30 minutes before induction. Patients will then receive a placebo on the evening of the surgery. Subsequently, patients will receive a placebo twice daily on the following four postoperative days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 3 months
Secondary outcomes (1)
Intensity of postoperative pain using a Visual Numeric Pain Scale (VNPS).
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Girard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967135
- Sponsor's protocol ID
- PC 2010-001
- Status last verified
- Apr 2012
- First submitted
- 26 Aug 2009
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.
- ClinicalTrials.gov ID
- NCT00967135
- Acronym / sponsor ID
- PC 2010-001
- Conditions
- Neuropathic Pain
- Keywords
- Thoracotomy, Neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess:
- 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.
- 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.
- The impact of taking perioperative pregabalin on the quality of life and level of functioning of patients who underwent thoracic surgery 3 months earlier.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinStudy subjects will be randomized to receive on the morning of surgery, at least 30 minutes before induction, a 150 mg oral dose of pregabalin. Patients will then receive a 150 mg oral dose of pregabalin on the evening of the surgery. Subsequently, patients will receive a 150 mg oral dose of pregabalin twice daily on the following four postoperative days. |
| Placebo | Placebo comparator | Drug: PlaceboStudy subjects will be randomized to receive a matching placebo on the morning of surgery, at least 30 minutes before induction. Patients will then receive a placebo on the evening of the surgery. Subsequently, patients will receive a placebo twice daily on the following four postoperative days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: Lyrica150 mg oral dose of pregabalin twice daily for 5 consecutive days. | Drug | Pregabalin |
| PlaceboMatching oral placebo twice daily for 5 consecutive days. | Drug | Placebo |
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).
Time frame: At 3 months
1 secondary outcome
Intensity of postoperative pain using a Visual Numeric Pain Scale (VNPS).
Time frame: Day 1 to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Girard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Neuropathic Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.