Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

March 21, 2019 updated by: Lynn Rusy, Medical College of Wisconsin

Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Gabapentin
Drug: Gabapentin
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
Other Names:
  • Neurontin
Drug: Morphine
Administered as needed
Placebo Comparator: 2
Placebo Comparator -- pill matched in appearance to gabapentin
Drug: Placebo
Drug: Morphine
Administered as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Morphine Consumed (mg/kg/hr)
Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Amount of Morphine Consumed (mg/kg/hr)
Time Frame: Day 1
Day 1
Amount of Morphine Consumed (mg/kg/hr)
Time Frame: Day 2
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Ondansetron Doses Administered for Nausea
Time Frame: First 10 days after surgery
The number of doses of Ondansetron given for nausea to participants in both groups.
First 10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin

Investigators

  • Principal Investigator: Lynn M Rusy, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/71,GC 138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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