Stanford Accelerated Recovery Trial (START)
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Cancer, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/4/2018 |
| Start Date: | May 2010 |
| End Date: | July 2016 |
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.
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.
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.
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.
INCLUSION CRITERIA
- Age 18 to 75
- Undergoing a scheduled surgery
- English speaking
- Ability and willingness to complete questionnaires or use Palm Pilot
EXCLUSION CRITERIA
- Known kidney disease
- Currently receiving gabapentin or (pregabalin) lyrica already
- Cognitive impairment
- Previous history of excessive sedation or adverse reaction to gabapentin (not it was
tried but ineffective for nerve pain)
- Coexisting chronic pain > 4/10 disorder in area other than surgical target
- Plan to move out of state
- Condition that would in judgment of team member make patient likely to be lost to
follow-up
- Elevated suicidality
- Known pregnancy
- Current symptoms of ataxia, dizziness, or sedation
- Narrow angle glaucoma
- Severe respiratory insufficiency (ie, severe emphysema or chronic obstructive
pulmonary disease)
- History of gastric bypass surgery and obstructive sleep apnea requiring continuous
positive airway pressure (CPAP)
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