Trial Outcomes & Findings for Stanford Accelerated Recovery Trial (START) (NCT NCT01067144)
NCT ID: NCT01067144
Last Updated: 2022-05-05
Results Overview
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.
TERMINATED
PHASE3
422 participants
Up to 2 years
2022-05-05
Participant Flow
1805 patients were assessed for eligibility; 422 were enrolled and randomized.
Participant milestones
| Measure |
Control
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Treatment
STARTED
|
207
|
215
|
|
Treatment
COMPLETED
|
203
|
208
|
|
Treatment
NOT COMPLETED
|
4
|
7
|
|
Follow-up
STARTED
|
203
|
208
|
|
Follow-up
Intention-to-Treat Analysis Set
|
202
|
208
|
|
Follow-up
COMPLETED
|
144
|
152
|
|
Follow-up
NOT COMPLETED
|
59
|
56
|
Reasons for withdrawal
| Measure |
Control
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Treatment
Did not receive allocated intervention
|
4
|
7
|
|
Follow-up
Lost to Follow-up
|
22
|
12
|
|
Follow-up
Censored owing to second surgery
|
19
|
28
|
|
Follow-up
Withdrawal by Subject
|
18
|
14
|
|
Follow-up
Surgery cancelled
|
0
|
1
|
|
Follow-up
Death
|
0
|
1
|
Baseline Characteristics
Data missing for 1 patient in each group.
Baseline characteristics by cohort
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 11.8 • n=202 Participants
|
57.0 years
STANDARD_DEVIATION 11.7 • n=208 Participants
|
56.7 years
STANDARD_DEVIATION 11.7 • n=410 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=201 Participants • Data missing for 1 patient in each group.
|
120 Participants
n=207 Participants • Data missing for 1 patient in each group.
|
243 Participants
n=408 Participants • Data missing for 1 patient in each group.
|
|
Sex: Female, Male
Male
|
78 Participants
n=201 Participants • Data missing for 1 patient in each group.
|
87 Participants
n=207 Participants • Data missing for 1 patient in each group.
|
165 Participants
n=408 Participants • Data missing for 1 patient in each group.
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Intention-to-Treat Analysis Set
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.
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Time to Pain Resolution
|
73 days
Interval 36.0 to 231.0
|
84 days
Interval 36.0 to 203.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Intention-to-Treat Analysis Set
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.
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Time to Opioid Cessation
|
32 days
Interval 9.0 to 88.0
|
25 days
Interval 8.0 to 53.0
|
SECONDARY outcome
Timeframe: Month 6Population: Intention-to-Treat Analysis Set
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).
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Count of Participants With Continued Pain at 6 Months
|
37 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Year 1Population: Intention-to-Treat Analysis Set
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).
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Count of Participants With Continued Pain at 1 Year
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Intention-to-Treat Analysis Set
Continued opioid use was defined as any report of any continued opioid use at Month 6.
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Count of Participants With Continued Opioid Use at 6 Months
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Year 1Population: Intention-to-Treat Analysis Set
Continued opioid use was defined as any report of any continued opioid use at Year 1.
Outcome measures
| Measure |
Control
n=202 Participants
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 Participants
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Count of Participants With Continued Opioid Use at 1 Year
|
3 Participants
|
4 Participants
|
Adverse Events
Control
Gabapentin
Serious adverse events
| Measure |
Control
n=202 participants at risk
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 participants at risk
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Postoperative hemodynamic instability
|
0.50%
1/202 • Up to 2 years
|
0.00%
0/208 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hematoma
|
0.50%
1/202 • Up to 2 years
|
0.00%
0/208 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/202 • Up to 2 years
|
0.48%
1/208 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/202 • Up to 2 years
|
0.48%
1/208 • Up to 2 years
|
Other adverse events
| Measure |
Control
n=202 participants at risk
Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.
|
Gabapentin
n=208 participants at risk
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
|
|---|---|---|
|
General disorders
Leg swelling
|
27.7%
56/202 • Up to 2 years
|
23.6%
49/208 • Up to 2 years
|
|
General disorders
Generalized weakness
|
60.4%
122/202 • Up to 2 years
|
57.2%
119/208 • Up to 2 years
|
|
Nervous system disorders
Headache
|
33.7%
68/202 • Up to 2 years
|
38.9%
81/208 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
21.8%
44/202 • Up to 2 years
|
14.4%
30/208 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
8/202 • Up to 2 years
|
5.3%
11/208 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
91.1%
184/202 • Up to 2 years
|
92.3%
192/208 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
72.8%
147/202 • Up to 2 years
|
61.5%
128/208 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
61.9%
125/202 • Up to 2 years
|
56.2%
117/208 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
27.2%
55/202 • Up to 2 years
|
23.6%
49/208 • Up to 2 years
|
|
Nervous system disorders
Impaired coordination
|
32.7%
66/202 • Up to 2 years
|
42.8%
89/208 • Up to 2 years
|
|
Nervous system disorders
Memory
|
35.6%
72/202 • Up to 2 years
|
36.1%
75/208 • Up to 2 years
|
|
Gastrointestinal disorders
Sore throat
|
55.9%
113/202 • Up to 2 years
|
50.0%
104/208 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
14/202 • Up to 2 years
|
13.0%
27/208 • Up to 2 years
|
|
Eye disorders
Visual disturbance
|
22.3%
45/202 • Up to 2 years
|
30.3%
63/208 • Up to 2 years
|
|
Eye disorders
Eye pain
|
9.4%
19/202 • Up to 2 years
|
12.5%
26/208 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place