Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00663962 |
Date of registration:
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18/04/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pregabalin and Post-thoracotomy Pain
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Scientific title:
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A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome |
Date of first enrolment:
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April 2008 |
Target sample size:
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15 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00663962 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jorge E Zamora, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Anesthesiology Queen's University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Elective thoracotomy (ET) or video assisted thoracotomy (VAT);
- Understanding and provision of written informed consent;
- Age > 18 and < 75;
- ASA class I, II or III.
Exclusion Criteria:
- Inability to adhere to study protocol;
- Intolerance or known hypersensitivity to any agents to be used in the study;
- Contraindication to thoracic epidural placement in open thoracotomy patients;
- Inability to respond to the study questionnaire;
- Renal insufficiency (serum creatinine > 1.5 x upper limit of normal);
- BMI > 40;
- Confounding procedural factors which might affect validity of data;
- Surgery for tumour extending into the chest wall;
- Requirement for second thoracotomy or re-occurrence of disease after surgery;
- Potential interaction with study medications and patient's current medications;
- Current ETOH or substance abuse;
- Pre-existing chronic pain requiring chronic analgesic use;
- History of seizure disorder requiring treatment with an anti-convulsant;
- Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos,
Avandia, or Avandamet);
- History of congestive heart failure;
- Major psychiatric disorder;
- Insufficient safety data in a specific patient population;
- Pregnant or breastfeeding.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Pain
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Intervention(s)
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Drug: Pregabalin
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Drug: Placebo
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Primary Outcome(s)
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Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively
[Time Frame: 2 months postoperatively]
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The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
[Time Frame: 2, 4, and 6 months]
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Secondary ID(s)
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ANAE-139-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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