Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Medical College of Wisconsin

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Morphine; Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT00726999

06/71,GC 138

Details and patient eligibility

About

Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).

Full description

Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.

Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine

No remifentanil, clonidine, ketamine

N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08

Enrollment: 63 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA 1-2, Idiopathic Scoliosis

Exclusion criteria

• ASA 3 or greater
• Neuromuscular scoliosis
• On narcotics baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Gabapentin

Treatment:

Drug: Morphine

Drug: Gabapentin

2

Placebo Comparator group

Description:

Placebo Comparator -- pill matched in appearance to gabapentin

Treatment:

Drug: Morphine

Drug: Placebo