Stanford Accelerated Recovery Trial (START)

Trial ID or NCT#

NCT01067144

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Stanford Accelerated Recovery Trial (START)

Eligibility Criteria

Ages Eligible for Study: 18 to 75
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Age 18 to 75* Undergoing a scheduled surgery* English speaking* Ability and willingness to complete questionnaires or use Palm Pilot
    1. EXCLUSION CRITERIA
  2. * 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)
Exclusion Criteria:
  1. * 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)
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Investigator(s)

Ian Carroll, MD, MS
Ian Carroll, MD, MS
Headache and facial pain specialist, Orofacial pain specialist, Headache specialist, Pain management specialist
Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain)
Peter Schmidt
Peter Schmidt
Anesthesiologist, Pain management specialist
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov