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Stanford Accelerated Recovery Trial (START)

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ClinicalTrials.gov Identifier: NCT01067144
Recruitment Status : Terminated (Trial met futility stopping point)
First Posted : February 11, 2010
Results First Posted : June 28, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ian Carroll, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Breast Cancer Lung Cancer Drug: Gabapentin Drug: Lorazepam (active control) Drug: Placebo (inactive) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stanford Accelerated Recovery Trial (START)
Study Start Date : May 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Drug: Lorazepam (active control)
0.5 mg Lorazepam (active control) given pre-operatively in a single dose.

Drug: Placebo (inactive)
2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.

Experimental: Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
Drug: Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
Other Names:
  • Fanatrex
  • Gabarone
  • Gralise
  • Neurontin
  • Nupentin




Primary Outcome Measures :
  1. Time to Pain Resolution [ Time Frame: Up to 2 years ]
    Time to pain resolution was defined as 5 consecutive reports of "0" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.


Secondary Outcome Measures :
  1. Time to Opioid Cessation [ Time Frame: Up to 2 years ]
    Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.

  2. Count of Participants With Continued Pain at 6 Months [ Time Frame: Month 6 ]
    Continued pain was defined as a report of at least "1" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain).

  3. Count of Participants With Continued Pain at 1 Year [ Time Frame: Year 1 ]
    Continued pain was defined as a report of at least "1" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain).

  4. Count of Participants With Continued Opioid Use at 6 Months [ Time Frame: Month 6 ]
    Continued opioid use was defined as any report of any continued opioid use at Month 6.

  5. Count of Participants With Continued Opioid Use at 1 Year [ Time Frame: Year 1 ]
    Continued opioid use was defined as any report of any continued opioid use at Year 1.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Age 18 to 75
  • Undergoing a scheduled surgery
  • English speaking
  • Ability and willingness to complete questionnaires or use Palm Pilot

EXCLUSION CRITERIA

  • Known kidney disease
  • Currently receiving gabapentin or (pregabalin) lyrica already
  • Cognitive impairment
  • Previous history of excessive sedation or adverse reaction to gabapentin (not it was tried but ineffective for nerve pain)
  • Coexisting chronic pain > 4/10 disorder in area other than surgical target
  • Plan to move out of state
  • Condition that would in judgment of team member make patient likely to be lost to follow-up
  • Elevated suicidality
  • Known pregnancy
  • Current symptoms of ataxia, dizziness, or sedation
  • Narrow angle glaucoma
  • Severe respiratory insufficiency (ie, severe emphysema or chronic obstructive pulmonary disease)
  • History of gastric bypass surgery and obstructive sleep apnea requiring continuous positive airway pressure (CPAP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067144


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ian R Carroll Stanford University

Publications of Results:
Responsible Party: Ian Carroll, Assistant Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01067144     History of Changes
Other Study ID Numbers: IRB-16617
SU-02032010-4882 ( Other Identifier: Stanford University )
VAR0054 ( Other Identifier: OnCore )
First Posted: February 11, 2010    Key Record Dates
Results First Posted: June 28, 2018
Last Update Posted: October 2, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Gabapentin
Lorazepam
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
GABA Modulators