Trial · NCT01067144
Stanford Accelerated Recovery Trial (START)
NCT01067144, Phase 3, Terminated, Stanford University; results first posted 2018-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stanford Accelerated Recovery Trial (START). Trials, record NCT01067144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01067144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stanford Accelerated Recovery Trial (START)
- NCT number
- NCT01067144
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 422 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Pain, Breast Cancer, Lung Cancer
- Interventions
- Gabapentin, Lorazepam (active control), Placebo (inactive)
- First posted
- 2010-02-11
- Last updated
- 2022-05-05
- Results first posted
- 2018-06-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Pain Resolution | Up to 2 years | 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. |
| Secondary | Time to Opioid Cessation | Up to 2 years | Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery. |
| Secondary | Count of Participants With Continued Pain at 6 Months | Month 6 | Continued pain was defined as a report of at least "1" 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). |
| Secondary | Count of Participants With Continued Pain at 1 Year | Year 1 | Continued pain was defined as a report of at least "1" 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). |
| Secondary | Count of Participants With Continued Opioid Use at 6 Months | Month 6 | Continued opioid use was defined as any report of any continued opioid use at Month 6. |
| Secondary | Count of Participants With Continued Opioid Use at 1 Year | Year 1 | Continued opioid use was defined as any report of any continued opioid use at Year 1. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Pain Resolution | Up to 2 years | Intention-to-Treat Analysis Set | days | MEDIAN |
| SECONDARY | Time to Opioid Cessation | Up to 2 years | Intention-to-Treat Analysis Set | days | MEDIAN |
| SECONDARY | Count of Participants With Continued Pain at 6 Months | Month 6 | Intention-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count of Participants With Continued Pain at 1 Year | Year 1 | Intention-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count of Participants With Continued Opioid Use at 6 Months | Month 6 | Intention-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count of Participants With Continued Opioid Use at 1 Year | Year 1 | Intention-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Pain Resolution | Control | 73 | Inter-Quartile Range 36 to 231 | days | |
| Time to Pain Resolution | Gabapentin | 84 | Inter-Quartile Range 36 to 203 | days | |
| Time to Opioid Cessation | Control | 32 | Inter-Quartile Range 9 to 88 | days | |
| Time to Opioid Cessation | Gabapentin | 25 | Inter-Quartile Range 8 to 53 | days | |
| Count of Participants With Continued Pain at 6 Months | Control | 37 | Participants | ||
| Count of Participants With Continued Pain at 6 Months | Gabapentin | 42 | Participants | ||
| Count of Participants With Continued Pain at 1 Year | Control | 18 | Participants | ||
| Count of Participants With Continued Pain at 1 Year | Gabapentin | 21 | Participants | ||
| Count of Participants With Continued Opioid Use at 6 Months | Control | 4 | Participants | ||
| Count of Participants With Continued Opioid Use at 6 Months | Gabapentin | 5 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Control | 207 | |
| Treatment | STARTED | Gabapentin | 215 | |
| Treatment | COMPLETED | Control | 203 | |
| Treatment | COMPLETED | Gabapentin | 208 | |
| Treatment | NOT COMPLETED | Control | 4 | |
| Treatment | NOT COMPLETED | Gabapentin | 7 | |
| Follow-up | STARTED | Control | 203 | |
| Follow-up | STARTED | Gabapentin | 208 | |
| Follow-up | Intention-to-Treat Analysis Set | Control | 202 | |
| Follow-up | Intention-to-Treat Analysis Set | Gabapentin | 208 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leg swelling | General disorders | Control | 56 | 202 | |
| other | Leg swelling | General disorders | Gabapentin | 49 | 208 | |
| other | Generalized weakness | General disorders | Control | 122 | 202 | |
| other | Generalized weakness | General disorders | Gabapentin | 119 | 208 | |
| other | Headache | Nervous system disorders | Control | 68 | 202 | |
| other | Headache | Nervous system disorders | Gabapentin | 81 | 208 | |
| other | Abdominal pain | Gastrointestinal disorders | Control | 44 | 202 | |
| other | Abdominal pain | Gastrointestinal disorders | Gabapentin | 30 | 208 | |
| other | Diarrhea | Gastrointestinal disorders | Control | 8 | 202 | |
| other | Diarrhea | Gastrointestinal disorders | Gabapentin | 11 | 208 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | Gabapentin | ||
| Total, other adverse events | Control | 191 | 202 |
| Total, other adverse events | Gabapentin | 208 | 208 |
| Total, serious adverse events | Control | 2 | 202 |
| Total, serious adverse events | Gabapentin | 2 | 208 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin vs Control: Count of Participants With Continued Opioid Use at 1 Year | Trial comparisons |
| Gabapentin vs Control: Count of Participants With Continued Opioid Use at 6 Months | Trial comparisons |
| Gabapentin vs Control: Count of Participants With Continued Pain at 1 Year | Trial comparisons |
| Gabapentin vs Control: Count of Participants With Continued Pain at 6 Months | Trial comparisons |
| Gabapentin vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01067144
GET https://conductscience.org/api/trials/v1/NCT01067144/events?page=2