Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

July 1, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

August 31, 2018

Conditions
Lumbar Spinal StenosisLumbar Spinal InstabilityLumbar Spine Degeneration
Interventions
DRUG

Standard analgesia use [Oxygen]

A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.

DRUG

Standard analgesia use [Hydromorphone]

A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.

DRUG

Standard analgesia use [Volatile Anesthesia]

A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.

DRUG

Standard analgesia use [Fentanyl]

A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.

DRUG

Multi-modal pain management [Acetaminophen + Gabapentin]

Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.

DRUG

Multi-modal pain management [Fentanyl]

Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.

DRUG

Multi-modal pain management [Intravenous Ketamine]

Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.

DRUG

Multi-modal pain management [Valium + Gabapentin]

Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.

Trial Locations (1)

21287

Johns Hopkins University School of Medicine, Baltimore

All Listed Sponsors
collaborator

North American Spine Society

UNKNOWN

lead

Johns Hopkins University

OTHER

NCT03088306 - Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients | Biotech Hunter | Biotech Hunter