Trial Outcomes & Findings for Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion (NCT NCT00726999)

NCT ID: NCT00726999

Last Updated: 2019-04-03

Results Overview

Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
• Results posted on: 2019-04-03

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	32	31
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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.
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	2	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Baseline characteristics by cohort

Measure	Gabapentin/Morphine n=32 Participants Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed.	Placebo/Morphine n=31 Participants Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.8 years STANDARD_DEVIATION 2.1 • n=5 Participants	14.2 years STANDARD_DEVIATION 1.8 • n=7 Participants	14.5 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Gabapentin/Morphine n=32 Participants Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed.	Placebo/Morphine n=31 Participants Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed.
Amount of Morphine Consumed (mg/kg/hr)	0.064 mg/kg/h Standard Deviation 0.031	0.044 mg/kg/h Standard Deviation 0.017

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Measure	Gabapentin/Morphine n=29 Participants Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed.	Placebo/Morphine n=30 Participants Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed.
Amount of Morphine Consumed (mg/kg/hr)	0.055 mg/kg/h Standard Deviation 0.017	0.046 mg/kg/h Standard Deviation 0.016

PRIMARY outcome

Timeframe: Day 2

Outcome measures

Measure	Gabapentin/Morphine n=29 Participants Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed.	Placebo/Morphine n=30 Participants Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed.
Amount of Morphine Consumed (mg/kg/hr)	0.047 mg/kg/h Standard Deviation 0.019	0.036 mg/kg/h Standard Deviation 0.016

SECONDARY outcome

Timeframe: First 10 days after surgery

The number of doses of Ondansetron given for nausea to participants in both groups.

Outcome measures

Measure	Gabapentin/Morphine n=29 Participants Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed.	Placebo/Morphine n=30 Participants Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed.
Number of Ondansetron Doses Administered for Nausea	2.0 doses of medication administered Interval 0.0 to 6.0	2.0 doses of medication administered Interval 0.0 to 3.75

Adverse Events

Gabapentin/Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Rusy, MD

Medical College of Wisconsin

Phone: 414-266-2555

Email: lrusy@chw.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place