Stanford Accelerated Recovery Trial (START)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stanford Accelerated Recovery Trial (START)

Conditions
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Pain, Breast Cancer, Lung Cancer

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Lorazepam (active control)
* Drug: Placebo (inactive)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively | Drug: Lorazepam (active control)<br>* 0.5 mg Lorazepam (active control) given pre-operatively in a single dose.<br>Drug: Placebo (inactive)<br>* 2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.<br>|
| Experimental: Gabapentin<br>1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period. | Drug: Gabapentin<br>* 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.<br>* Other names: Nupentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Pain Resolution | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Opioid Cessation | 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. | Up to 2 years | 
| Count of Participants With Continued Pain at 6 Months | 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). | Month 6 | 
| Count of Participants With Continued Pain at 1 Year | 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). | Year 1 | 
| Count of Participants With Continued Opioid Use at 6 Months | Continued opioid use was defined as any report of any continued opioid use at Month 6. | Month 6 | 
| Count of Participants With Continued Opioid Use at 1 Year | Continued opioid use was defined as any report of any continued opioid use at Year 1. | Year 1 |