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Stanford Accelerated Recovery Trial (START)

NCT01067144 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2022-05-05

Study results available
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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.

Conditions

Interventions

DRUG

Gabapentin

1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.

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.

Sponsors & Collaborators

Principal Investigators

  • Ian R Carroll · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-07-31
Completion
2016-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01067144 on ClinicalTrials.gov