TerminatedPhase 3NCT01067144
Official study title

Stanford Accelerated Recovery Trial (START)

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedGabapentin and Lorazepam (active control)

Plus 1 other study approaches.

Who it may be forPain · Breast Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 5, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Stanford University

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 3
Sponsor
Stanford University
Interventions being studied
Drug: Gabapentin; Drug: Lorazepam (active control); Drug: Placebo (inactive)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Age 18 to 75
  • Undergoing a scheduled surgery
  • English speaking
  • Ability and willingness to complete questionnaires or use Palm Pilot
Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford University School of MedicineStanford, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 5, 2022. Always confirm current availability with the study team.

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