Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Lung Neoplasms

Breast Neoplasms

Pain

Anticonvulsants

Antiemetics

Central Nervous System Depressants

Psychotropic Drugs

Gastrointestinal Agents

All Drugs and Chemicals

Analgesics

Lorazepam

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Hypnotics and Sedatives

GABA Modulators

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

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

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

Lorazepam (active control)

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

Placebo (inactive)

Ian R Carroll

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.

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.

Stanford Accelerated Recovery Trial (START)

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 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.

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).

Continued opioid use was defined as any report of any continued opioid use at Month 6.

Continued opioid use was defined as any report of any continued opioid use at Year 1.

Stanford University

Assistant Professor of Anesthesiology, Perioperative and Pain Medicine

Active placebo (lorazepam 0.5 mg) given pre-operatively, followed by inactive placebo for 10 doses post-operatively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stanford Accelerated Recovery Trial (START)	NCT01067144	Pain Breast Cancer Lung Cancer	Gabapentin Lorazepam (acti... Placebo (inacti...	18 Years - 75 Years	Stanford University
Stanford Accelerated Recovery Trial (START)	NCT01067144	Pain Breast Cancer Lung Cancer	Gabapentin Lorazepam (acti... Placebo (inacti...	18 Years - 75 Years	Stanford University

Spots Global Cancer Trial Database for placebo (inactive)