Clinical trial NCT01067144: Stanford Accelerated Recovery Trial (START)
Official title: Stanford Accelerated Recovery Trial (START)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Breast Cancer
Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Time to Pain Resolution
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to Opioid Cessation
timeFrame: Up to 2 years
measure: Count of Participants With Continued Pain at 6 Months
timeFrame: Month 6
measure: Count of Participants With Continued Pain at 1 Year
timeFrame: Year 1
measure: Count of Participants With Continued Opioid Use at 6 Months
timeFrame: Month 6
measure: Count of Participants With Continued Opioid Use at 1 Year
timeFrame: Year 1
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ian R Carroll
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
citation: Hah JM, Cramer E, Hilmoe H, Schmidt P, McCue R, Trafton J, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Mackey SC, Carroll I. Factors Associated With Acute Pain Estimation, Postoperative Pain Resolution, Opioid Cessation, and Recovery: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190168. doi: 10.1001/jamanetworkopen.2019.0168.