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

February 9, 2010
February 11, 2010
June 24, 2016
May 2010
July 2016   (Final data collection date for primary outcome measure)
Time to pain resolution [ Time Frame: Daily during trial participation ]
Same as current
Complete list of historical versions of study NCT01067144 on Archive Site
Time to opioid cessation [ Time Frame: Daily during trial participation ]
Same as current
Not Provided
Not Provided
Stanford Accelerated Recovery Trial (START)
Stanford Accelerated Recovery Trial (START)
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Pain
  • Breast Cancer
  • Lung Cancer
  • 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
  • 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.
  • Placebo Comparator: Placebo
    Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
    Intervention: Drug: Placebo
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
May 2024
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
SU-02032010-4882 ( Other Identifier: Stanford University )
Not Provided
Not Provided
Stanford University
Stanford University
Not Provided
Principal Investigator: Ian R Carroll Stanford University
Stanford University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP