Stanford Accelerated Recovery Trial (START)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Breast Cancer Lung Cancer |
Drug: Gabapentin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Stanford Accelerated Recovery Trial (START) |
- Time to pain resolution [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]
- Time to opioid cessation [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2024 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
|
Drug: Placebo
Active placebo given pre-operatively (0.5mg Lorazepam) in a single dose. 2 capsules of inactive placebo given three times a day post-operatively for the 72 hour post-surgical period.
|
| Experimental: Gabapentin |
Drug: Gabapentin
1200mg Gabapentin preoperative dose, 300mg of Gabapentin three times a day postoperative doses for 72 hour post-surgical period.
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-75
- Undergoing a scheduled surgery
- English speaking
- Ability and willingness to complete questionnaires or use palm pilot
Exclusion Criteria:
- Known kidney disease
- On 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 (i.e. severe emphysema or chronic obstructive pulmonary disease)
Contacts and Locations| Contact: Debra Clay, RN | 6507241753 | debra.clay@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Debra Clay 650-724-1753 debra.clay@stanford.edu | |
| Principal Investigator: Ian R Carroll | |
| Principal Investigator: Sean Mackey | |
| Principal Investigator: | Ian R Carroll | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01067144 History of Changes |
| Other Study ID Numbers: | VAR0054, SU-02032010-4882 |
| Study First Received: | February 9, 2010 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013