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
  Purpose

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 Intervention Phase
Pain
Breast Cancer
Lung Cancer
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stanford Accelerated Recovery Trial (START)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time to pain resolution [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to opioid cessation [ Time Frame: Daily during trial participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: May 2010
Estimated Study Completion Date: May 2024
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067144

Contacts
Contact: Debra Clay, RN 6507241753 debra.clay@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Debra Clay    650-724-1753    debra.clay@stanford.edu   
Principal Investigator: Ian R Carroll         
Principal Investigator: Sean Mackey         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ian R Carroll Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01067144     History of Changes
Other Study ID Numbers: VAR0054, SU-02032010-4882
Study First Received: February 9, 2010
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 16, 2014