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With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.
Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative pregabalin | Experimental | Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4). |
|
| Placebo control | Placebo Comparator | An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months. | 2, 4, and 6 months | |
| Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively | Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale) | 2 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge E Zamora, MD | Department of Anesthesiology Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L2V7 | Canada |
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Thirty-nine patients were screened between April 23 and November 27, 2008. Fifteen patients were eligible for inclusion.
REB approval from our institution was received to enroll 15 patients, who had given written informed consent, into this pilot study. All elective ASA I - III patients aged 18 - 75 scheduled for open thoracotomy or video assisted thoracotomy (VAT) were screened for inclusion in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. |
| FG001 | Placebo | An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 7 participants randomized to the pregabalin group, 3 receieved 150mg of pregabalin while 4 recieved 300mg pregabalin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months. | Not Posted | 2, 4, and 6 months | |||||||||||||
| Primary | Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively | Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale) | pilot study--convenience | Posted | Number | participants | 2 months postoperatively |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | General disorders | Non-systematic Assessment | sleepiness with 300 mg pregabalin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pregabalin and Post-thoracotomy pain | Queen's University | (613) 548-7827 | zamoraj@kgh.kari.net |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Placebo | Drug | An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8) |
|
| Placebo |
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Placebo | An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8) | 0 | 8 | 0 | 8 |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |