Overview
Stanford Accelerated Recovery Trial (START)
Status:
Terminated
Terminated
Trial end date:
2016-07-01
2016-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Stanford UniversityTreatments:
Gabapentin
Lorazepam
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)