Study Stopped
Trial met futility stopping point
Stanford Accelerated Recovery Trial (START)
3 other identifiers
interventional
422
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started May 2010
Longer than P75 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
June 28, 2018
CompletedMay 5, 2022
May 1, 2022
6.2 years
February 9, 2010
June 1, 2018
May 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Pain Resolution
Time to pain resolution was defined as 5 consecutive reports of "0" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.
Up to 2 years
Secondary Outcomes (5)
Time to Opioid Cessation
Up to 2 years
Count of Participants With Continued Pain at 6 Months
Month 6
Count of Participants With Continued Pain at 1 Year
Year 1
Count of Participants With Continued Opioid Use at 6 Months
Month 6
Count of Participants With Continued Opioid Use at 1 Year
Year 1
Study Arms (2)
Control
PLACEBO COMPARATORActive placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
Gabapentin
EXPERIMENTAL1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
Interventions
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
0.5 mg Lorazepam (active control) given pre-operatively in a single dose.
2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.
Eligibility Criteria
You may qualify if:
- Age 18 to 75
- Undergoing a scheduled surgery
- English speaking
- Ability and willingness to complete questionnaires or use Palm Pilot
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
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.
PMID: 29238824RESULTHah 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.
PMID: 30821824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ian Carroll
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Ian R Carroll
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology, Perioperative and Pain Medicine
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 11, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
May 5, 2022
Results First Posted
June 28, 2018
Record last verified: 2022-05