Stanford Accelerated Recovery Trial (START)
Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Breast Cancer; Lung Cancer
Intervention: Gabapentin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Ian R Carroll, Principal Investigator, Affiliation: Stanford University
Overall contact: Debra Clay, RN, Phone: 6507241753, Email: debra.clay@stanford.edu
Summary
The goal of this study is to determine whether administering Gabapentin prior to surgery
affects duration of pain and opioid use post-surgery. The investigators aim to compare
gabapentin to placebo in a prospective, randomized clinical trial in which patients will be
followed post-surgery until pain resolves and opioid use ceases.
Clinical Details
Official title: Stanford Accelerated Recovery Trial (START)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Time to pain resolution
Secondary outcome: Time to opioid cessation
Detailed description:
Gabapentin was originally developed as an anti-convulsant, but was quickly recognized as a
medication with significant analgesic activity in patients with neuropathic pain. More
recently it has begun to be appreciated that it may have some benefits in the peri-operative
period. Pre-operative Gabapentin reduces preoperative anxiety, early post-operative pain
severity, post-operative opioid use and post-operative delirium (presumably through reduced
opioid consumption). These same attributes are shared by medications such as NSAIDS and
tylenol and the use of peri-operative gabapentin has not permeated the standard of care.
Early post-operative pain severity and preoperative anxiety have been implicated in our own
research as risk factors for prolonged time to pain resolution and prolonged time to opioid
cessation. Since these endpoints are generally synonymous with time to recovery,
interventions reducing these times would be seen not just to increase comfort but to
actually speed recovery.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
13. History of gastric bypass surgery and obstructive sleep apnea requiring CPAP
Locations and Contacts
Debra Clay, RN, Phone: 6507241753, Email: debra.clay@stanford.edu
Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting Debra Clay, Phone: 650-724-1753, Email: debra.clay@stanford.edu Ian R Carroll, Principal Investigator Sean Mackey, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: October 24, 2013
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