Stanford Accelerated Recovery Trial (START)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01067144

Enrollment

422

Registered

2010-02-11

Start date

2010-05-31

Completion date

2016-07-31

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lung Cancer, Pain

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.

Interventions

DRUGGabapentin

1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.

DRUGLorazepam (active control)

0.5 mg Lorazepam (active control) given pre-operatively in a single dose.

DRUGPlacebo (inactive)

2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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).
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).
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.
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.

Countries

United States

Participant flow

Pre-assignment details

1805 patients were assessed for eligibility; 422 were enrolled and randomized.

Participants by arm

Arm	Count
Control Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.	202
Gabapentin 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.	208
Total	410

Withdrawals & dropouts

Period	Reason	FG000	FG001
Follow-up	Censored owing to second surgery	19	28
Follow-up	Death	0	1
Follow-up	Lost to Follow-up	22	12
Follow-up	Surgery cancelled	0	1
Follow-up	Withdrawal by Subject	18	14
Treatment	Did not receive allocated intervention	4	7

Baseline characteristics

Characteristic	Control	Gabapentin	Total
Age, Continuous	56.4 years STANDARD_DEVIATION 11.8	57.0 years STANDARD_DEVIATION 11.7	56.7 years STANDARD_DEVIATION 11.7
Sex: Female, Male Female	123 Participants	120 Participants	243 Participants
Sex: Female, Male Male	78 Participants	87 Participants	165 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	191 / 202	208 / 208
serious Total, serious adverse events	2 / 202	2 / 208

Outcome results

Primary

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.

Time frame: Up to 2 years