Stanford Accelerated Recovery Trial (START)
Conditions
Pain - Breast Cancer - Lung Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Gabapentin Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Debra Clay - 650-724-1753 - debra.clay@stanford.edu
Start Date
May 2010
Completion Date
May 2024
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page