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Stanford Accelerated Recovery Trial (START)

Phase 3
18 Years
75 Years
Open (Enrolling)
Pain, Breast Cancer, Lung Cancer

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Trial Information

Stanford Accelerated Recovery Trial (START)

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

Time to pain resolution

Outcome Time Frame:

Daily during trial participation

Safety Issue:


Principal Investigator

Ian R Carroll

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

May 2024

Related Keywords:

  • Pain
  • Breast Cancer
  • Lung Cancer
  • Breast Neoplasms
  • Lung Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317