Stanford Accelerated Recovery Trial (START)

Breast Cancer Clinical Trial

Official title:

Stanford Accelerated Recovery Trial (START)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067144
• Other study ID #: IRB-16617
• Secondary ID: SU-02032010-4882
• Status: Terminated
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 422
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Pain

Intervention

Drug:
• Gabapentin
1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
• Lorazepam (active control)
0.5 mg Lorazepam (active control) given pre-operatively in a single dose.
• Placebo (inactive)
2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Pai — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 2 years
Secondary	Time to Opioid Cessation	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.	Up to 2 years
Secondary	Count of Participants With Continued Pain at 6 Months	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).	Month 6
Secondary	Count of Participants With Continued Pain at 1 Year	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).	Year 1
Secondary	Count of Participants With Continued Opioid Use at 6 Months	Continued opioid use was defined as any report of any continued opioid use at Month 6.	Month 6
Secondary	Count of Participants With Continued Opioid Use at 1 Year	Continued opioid use was defined as any report of any continued opioid use at Year 1.	Year 1