Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

This study has been completed.

Study NCT00726999 Information provided by Medical College of Wisconsin

First Received on July 30, 2008. Last Updated on January 3, 2011 History of Changes

Results First Received: August 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Postoperative Pain
Interventions:	Drug: Gabapentin Drug: Placebo Drug: Morphine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Gabapentin/Morphine	Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
Placebo/Morphine	Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.

Participant Flow: Overall Study

	Gabapentin/Morphine	Placebo/Morphine
STARTED	32	31
COMPLETED	29	30
NOT COMPLETED	3	1
Physician Decision	0	1
Withdrawal by Subject	2	0
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Gabapentin/Morphine	Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
Placebo/Morphine	Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.

Baseline Measures

	Gabapentin/Morphine	Placebo/Morphine	Total
Number of Participants [units: participants]	32	31	63
Age [units: participants]
<=18 years	32	31	63
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	14.8 ± 2.1	14.2 ± 1.8	14.5 ± 2.0
Gender [units: participants]
Female	23	24	47
Male	9	7	16

Outcome Measures

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1. Primary:

Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) ]

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2. Primary:

Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 1 ]

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3. Primary:

Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 2 ]

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4. Secondary:

Side Effect Occurrence [ Time Frame: First 10 days after surgery ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Lynn Rusy, MD
Organization: Medical College of Wisconsin
phone: 414-266-2555
e-mail: lrusy@chw.org

No publications provided

Responsible Party:	Dr. Lynn M. Rusy, Medical College of Wisconsin Anesthesia Department
ClinicalTrials.gov Identifier:	NCT00726999 History of Changes
Other Study ID Numbers:	06/71,GC 138
Study First Received:	July 30, 2008
Results First Received:	August 19, 2010
Last Updated:	January 3, 2011
Health Authority:	United States: Food and Drug Administration