Stanford Accelerated Recovery Trial (START)
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.
|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 ]
|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)|
Placebo Comparator: Placebo
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
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.
1200mg Gabapentin preoperative dose, 300mg of Gabapentin three times a day postoperative doses for 72 hour post-surgical period.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067144
|Contact: Debra Clay, RNfirstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Debra Clay 650-724-1753 email@example.com|
|Principal Investigator: Ian R Carroll|
|Principal Investigator: Sean Mackey|
|Principal Investigator:||Ian R Carroll||Stanford University|