Stanford Accelerated Recovery Trial (START)

NCT ID: NCT01067144

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2016-07-31

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.

Conditions

Pain; Breast Cancer; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively

Group Type: PLACEBO_COMPARATOR

Lorazepam (active control)

Intervention Type: DRUG

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

Placebo (inactive)

Intervention Type: DRUG

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

Gabapentin

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

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

Interventions

Gabapentin

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

Intervention Type: DRUG

Lorazepam (active control)

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

Intervention Type: DRUG

Placebo (inactive)

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

Intervention Type: DRUG

Other Intervention Names

Fanatrex; Gabarone; Gralise; Neurontin; Nupentin

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Hah

Assistant Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian R Carroll

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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 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.

Reference Type: RESULT

PMID: 29238824 (View on PubMed)

Hah 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.

Reference Type: DERIVED

PMID: 30821824 (View on PubMed)

Other Identifiers

SU-02032010-4882

Identifier Type: OTHER

Identifier Source: secondary_id

VAR0054

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-16617

Identifier Type: -

Identifier Source: org_study_id