This trial is active, not recruiting.

Conditions pain, breast cancer, lung cancer
Treatments gabapentin, placebo
Phase phase 3
Target Hsp90
Sponsor Stanford University
Start date May 2010
End date July 2016
Trial size 560 participants
Trial identifier NCT01067144, SU-02032010-4882, VAR0054


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
(Placebo Comparator)
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
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.
gabapentin Fanatrex
1200mg Gabapentin preoperative dose, 300mg of Gabapentin three times a day postoperative doses for 72 hour post-surgical period.

Primary Outcomes

Time to pain resolution
time frame: Daily during trial participation

Secondary Outcomes

Time to opioid cessation
time frame: Daily during trial participation

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Stanford Accelerated Recovery Trial (START)
Principal investigator Ian R Carroll
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stanford University.