Clinical trial · Interventional
Stanford Accelerated Recovery Trial (START)
NCT01067144CI-TRIAL-00058270terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial met futility stopping point
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Lorazepam (active control) | Drug | — | UNRESOLVED |
| Placebo (inactive) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively
- interventionNames
- Drug: Lorazepam (active control)
- Drug: Placebo (inactive)
- type
- EXPERIMENTAL
- label
- Gabapentin
- description
- 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
- interventionNames
- Drug: Gabapentin
Primary outcomes (1)
- measure
- Time to Pain Resolution
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (2)
- RESULTHah 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 29238824
- DERIVEDHah 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 30821824