Stanford Accelerated Recovery Trial (START)

Stanford University

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Lung Cancer; Pain

Treatments: Drug: Lorazepam (active control); Drug: Gabapentin; Drug: Placebo (inactive)

Study type: Interventional

Funder types: Other

Identifiers

NCT01067144

SU-02032010-4882 (Other Identifier)

VAR0054 (Other Identifier)

IRB-16617

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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422 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively

Treatment:

Drug: Lorazepam (active control)

Drug: Placebo (inactive)

Gabapentin

Experimental group

Description:

1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.

Treatment:

Drug: Gabapentin