Stanford Accelerated Recovery Trial (START)

Phase 3

Terminated

Interventions: Drug: Lorazepam (active control)
Drug: Gabapentin
Drug: Placebo (inactive)

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Control	Placebo (inactive)	Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Control	Lorazepam (active control)	Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Gabapentin	Gabapentin	1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.

Primary Outcome Measures

Name	Time	Method
Time to Pain Resolution	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 Outcome Measures

Name	Time	Method
Count of Participants With Continued Opioid Use at 1 Year	Year 1	Continued opioid use was defined as any report of any continued opioid use at Year 1.
Count of Participants With Continued Pain at 1 Year	Year 1	Continued pain was defined as a report of at least "1" 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).
Time to Opioid Cessation	Up to 2 years	Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.
Count of Participants With Continued Pain at 6 Months	Month 6	Continued pain was defined as a report of at least "1" 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).
Count of Participants With Continued Opioid Use at 6 Months	Month 6	Continued opioid use was defined as any report of any continued opioid use at Month 6.