Stanford Accelerated Recovery Trial (START)

Condition(s) targeted: Pain; Breast Cancer; Lung Cancer

Intervention: Gabapentin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Ian R Carroll, Principal Investigator, Affiliation: Stanford University

Overall contact:
Debra Clay, RN, Phone: 6507241753, Email: debra.clay@stanford.edu

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.

Official title: Stanford Accelerated Recovery Trial (START)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Time to pain resolution

Secondary outcome: Time to opioid cessation

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 18-75 2. Undergoing a scheduled surgery 3. English speaking 4. Ability and willingness to complete questionnaires or use palm pilot Exclusion Criteria: 1. Known kidney disease 2. On gabapentin or (pregabalin) lyrica already 3. Cognitive impairment 4. Previous history of excessive sedation or adverse reaction to gabapentin (not it was tried but ineffective for nerve pain) 5. Coexisting chronic pain >4/10 disorder in area other than surgical target 6. Plan to move out of state 7. Condition that would in judgment of team member make patient likely to be lost to follow up 8. elevated Suicidality 9. Known pregnancy 10. Current symptoms of ataxia, dizziness, or sedation 11. Narrow angle glaucoma 12. Severe respiratory insufficiency (i. e. severe emphysema or chronic obstructive pulmonary disease) 13. History of gastric bypass surgery and obstructive sleep apnea requiring CPAP

Debra Clay, RN, Phone: 6507241753, Email: debra.clay@stanford.edu

Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Debra Clay, Phone: 650-724-1753, Email: debra.clay@stanford.edu
Ian R Carroll, Principal Investigator
Sean Mackey, Principal Investigator

Starting date: May 2010
Last updated: October 24, 2013