Stanford Accelerated Recovery Trial (START)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01067144
First received: February 9, 2010
Last updated: October 24, 2013
Last verified: October 2013

February 9, 2010
October 24, 2013
May 2010
May 2014   (final data collection date for primary outcome measure)
Time to pain resolution [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067144 on ClinicalTrials.gov Archive Site
Time to opioid cessation [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
May 2024
May 2014   (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
Both
18 Years to 75 Years
No
Contact: Debra Clay, RN 6507241753 debra.clay@stanford.edu
United States
 
NCT01067144
VAR0054, SU-02032010-4882
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Ian R Carroll Stanford University
Stanford University
October 2013

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