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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01067144 |
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Date of registration:
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09/02/2010 |
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Primary sponsor: |
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Public title:
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Stanford Accelerated Recovery Trial (START)
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Scientific title:
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Stanford Accelerated Recovery Trial (START) |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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560 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01067144 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Debra Clay |
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Address:
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Telephone:
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650-724-1753 |
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Email:
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debra.clay@stanford.edu |
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Affiliation:
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Name:
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Debra Clay, RN |
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Address:
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Telephone:
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6507241753 |
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Email:
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debra.clay@stanford.edu |
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Affiliation:
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Name:
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Ian R Carroll |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18-75
2. Undergoing a scheduled surgery
3. English speaking
4. Ability and willingness to complete questionnaires or use palm pilot
Exclusion Criteria:
1. Known kidney disease
2. On gabapentin or (pregabalin) lyrica already
3. Cognitive impairment
4. Previous history of excessive sedation or adverse reaction to gabapentin (not it was
tried but ineffective for nerve pain)
5. Coexisting chronic pain >4/10 disorder in area other than surgical target
6. Plan to move out of state
7. Condition that would in judgment of team member make patient likely to be lost to
follow up
8. elevated Suicidality
9. Known pregnancy
10. Current symptoms of ataxia, dizziness, or sedation
11. Narrow angle glaucoma
12. Severe respiratory insufficiency (i.e. severe emphysema or chronic obstructive
pulmonary disease)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Lung Cancer
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Pain
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Intervention(s)
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Drug: Gabapentin
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Drug: Placebo
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Primary Outcome(s)
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Time to pain resolution
[Time Frame: Daily during trial participation]
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Secondary Outcome(s)
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Time to opioid cessation
[Time Frame: Daily during trial participation]
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Secondary ID(s)
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SU-02032010-4882
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VAR0054
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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