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

Summary

Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.

Conditions

• Lumbar Spinal Stenosis
• Lumbar Spinal Instability
• Lumbar 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.

Sponsors & Collaborators

• North American Spine Society

  collaborator UNKNOWN

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Richard L Skolasky, ScD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2018-05-31

Completion

2018-08-31

FDA Drug

Yes

Countries

• United States

Study Locations