Stanford Accelerated Recovery Trial (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067144
Recruitment Status : Active, not recruiting
First Posted : February 11, 2010
Last Update Posted : June 24, 2016
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Pain Breast Cancer Lung Cancer Drug: Gabapentin Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stanford Accelerated Recovery Trial (START)
Study Start Date : May 2010
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to pain resolution [ Time Frame: Daily during trial participation ]

Secondary Outcome Measures :
  1. Time to opioid cessation [ Time Frame: Daily during trial participation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stanford University Identifier: NCT01067144     History of Changes
Other Study ID Numbers: VAR0054
SU-02032010-4882 ( Other Identifier: Stanford University )
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

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