Stanford Accelerated Recovery Trial (START)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stanford University Identifier:
First received: February 9, 2010
Last updated: August 25, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Breast Cancer
Lung Cancer
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stanford Accelerated Recovery Trial (START)

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time to pain resolution [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to opioid cessation [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: May 2010
Estimated Study Completion Date: May 2024
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Drug: Placebo
Active placebo given pre-operatively (0.5mg Lorazepam) in a single dose. 2 capsules of inactive placebo given three times a day post-operatively for the 72 hour post-surgical period.
Experimental: Gabapentin Drug: Gabapentin
1200mg Gabapentin preoperative dose, 300mg of Gabapentin three times a day postoperative doses for 72 hour post-surgical period.
Other Names:
  • Fanatrex
  • Gabarone
  • Gralise
  • Neurontin
  • Nupentin

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01067144

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Ian R Carroll Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT01067144     History of Changes
Other Study ID Numbers: VAR0054  SU-02032010-4882 
Study First Received: February 9, 2010
Last Updated: August 25, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents processed this record on May 26, 2016