Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Gabapentin; Drug: Morphine

• Registration Number: NCT00726999
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Study Completion: 2009-05
• Results First Submitted: 2010-08-19
• Results First Submitted QC: 2010-12-28
• Results First Posted: 2010-12-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo Comparator -- pill matched in appearance to gabapentin
1	Gabapentin	Gabapentin
1	Morphine	Gabapentin
2	Morphine	Placebo Comparator -- pill matched in appearance to gabapentin

Primary Outcome Measures

Name	Time	Method
Amount of Morphine Consumed (mg/kg/hr)	Day 2

Secondary Outcome Measures

Name	Time	Method
Number of Ondansetron Doses Administered for Nausea	First 10 days after surgery	The number of doses of Ondansetron given for nausea to participants in both groups.