Stanford Accelerated Recovery Trial (START)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 422
- Locations
- 1
- Primary Endpoint
- Time to Pain Resolution
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Intervention: Lorazepam (active control) (Drug)
Control
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Intervention: Placebo (inactive) (Drug)
Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
Intervention: Gabapentin (Drug)
Outcomes
Primary Outcomes
Time to Pain Resolution
Time Frame: Up to 2 years
Time to pain resolution was defined as 5 consecutive reports of "0" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.
Secondary Outcomes
- Count of Participants With Continued Opioid Use at 1 Year(Year 1)
- Count of Participants With Continued Pain at 1 Year(Year 1)
- Time to Opioid Cessation(Up to 2 years)
- Count of Participants With Continued Pain at 6 Months(Month 6)
- Count of Participants With Continued Opioid Use at 6 Months(Month 6)
Investigators
Jennifer Hah
Assistant Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University