Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

NCT ID: NCT00726999

Last Updated: 2019-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-05-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge

Morphine

Intervention Type DRUG

Administered as needed

2

Placebo Comparator -- pill matched in appearance to gabapentin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Morphine

Intervention Type DRUG

Administered as needed

Interventions

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Gabapentin

oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge

Intervention Type DRUG

Placebo

Intervention Type DRUG

Morphine

Administered as needed

Intervention Type DRUG

Other Intervention Names

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Neurontin

Eligibility Criteria

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Inclusion Criteria

* ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria

* ASA 3 or greater
* Neuromuscular scoliosis
* On narcotics baseline
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Lynn Rusy

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynn M Rusy, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Other Identifiers

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06/71,GC 138

Identifier Type: -

Identifier Source: org_study_id

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