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

NCT03088306 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB00113816
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants undergoing lumbar spine surgery with complete follow-up

  Number of participants undergoing lumbar spine surgery with complete follow-up

  52 week

Secondary Outcomes (11)

• Patient controlled analgesia (PCA) pump use

  during surgical hospitalization, up to 12 weeks

• Opioid medication use

  up to 90 days

• Patient Reported Outcomes Measurement Information System (PROMIS) Pain

  at 6 and 12 weeks

• PROMIS Physical Function

  at 6 and 12 weeks

• PROMIS Fatigue

  at 6 and 12 weeks

Study Arms (2)

Standard analgesia use

ACTIVE COMPARATOR

A strategy to manage pain in the peri-operative period that is in common clinical use.

Drug: Standard analgesia use [Oxygen]; Drug: Standard analgesia use [Hydromorphone]; Drug: Standard analgesia use [Volatile Anesthesia]; Drug: Standard analgesia use [Fentanyl]

Multi-modal pain management

ACTIVE COMPARATOR

A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication.

Drug: Multi-modal pain management [Acetaminophen + Gabapentin]; Drug: Multi-modal pain management [Fentanyl]; Drug: Multi-modal pain management [Intravenous Ketamine]; Drug: Multi-modal pain management [Valium + Gabapentin]

Interventions

Standard analgesia use [Oxygen] DRUG

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

Standard analgesia use

Standard analgesia use [Hydromorphone] DRUG

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

Standard analgesia use

Standard analgesia use [Volatile Anesthesia] DRUG

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

Standard analgesia use

Standard analgesia use [Fentanyl] DRUG

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

Standard analgesia use

Multi-modal pain management [Acetaminophen + Gabapentin] DRUG

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.

Multi-modal pain management

Multi-modal pain management [Fentanyl] DRUG

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.

Multi-modal pain management

Multi-modal pain management [Intravenous Ketamine] DRUG

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.

Multi-modal pain management

Multi-modal pain management [Valium + Gabapentin] DRUG

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.

Multi-modal pain management

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be English-speaking adults who are presenting to a spine surgeon (orthopaedic or neurosurgeon) for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e. fusion).

You may not qualify if:

• A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy.
• Spinal deformity as the primary indication for surgery.
• Spine surgery secondary to pseudarthrosis, trauma, infection, or tumor.
• Back and/or lower extremity pain \< 3 months indicating no history of sub-acute or chronic pain.
• History of neurological disorder or disease, resulting in moderate to severe movement dysfunction.
• Presence of schizophrenia or other psychotic disorder.
• Patient refusal to participate.
• Known allergic reactions to any of the study medications
• Surgery under a workman's compensation claim.
• Not able to return to clinic for standard follow-up visits with surgeon.
• Unable to provide a stable address and access to a telephone.

Sponsors & Collaborators

• Johns Hopkins University: lead
• North American Spine Society: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Oxygen; Hydromorphone; Fentanyl; Acetaminophen; Gabapentin; Diazepam

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• Richard L Skolasky, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 23, 2017
• Study Start: July 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)