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

Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Lumbar Spine Degeneration; Lumbar Spinal Instability
• Intervention / Treatment: Drug: Standard analgesia use [Oxygen]; Drug: Standard analgesia use [Hydromorphone]; Drug: Standard analgesia use [Volatile Anesthesia]; Drug: Standard analgesia use [Fentanyl]; 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]

Detailed Description

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. Proper pain management is necessary to reduce pain-related and medication side effects and to promote rehabilitation. 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.

Multi-modal pain management strategies have been proposed to (1) control pre-operative pain related to spine pathology; (2) employ non-opioid medication peri-operatively to pre-empt post-operative surgical pain; and (3) monitor and control pain intensity before and after surgery. There is a demonstrated lack of evidence regarding optimal post-operative protocols and pathways. The investigators have planned a randomized clinical trial to compare the effectiveness of two methods of peri-operative pain management to reduce post-operative pain and opioid use among patients undergoing lumbar spine surgery.

Prior to submission to National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), or Patient Centered Outcomes Research Institute (PCORI), it is necessary to demonstrate the feasibility and acceptability of the trial protocol. 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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard analgesia use; A strategy to manage pain in the peri-operative period that is in common clinical use.	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.
Active Comparator: Multi-modal pain management; 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]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient controlled analgesia (PCA) pump use	Total morphine equivalent of opioids administered by the PCA pump	during surgical hospitalization, up to 12 weeks
Opioid medication use	How many patients were prescribed and using opioid medication over the 90 days after hospital discharge?	up to 90 days
Patient Reported Outcomes Measurement Information System (PROMIS) Pain	Measure of pain intensity; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Physical Function	Measure of physical function; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Fatigue	Measure of fatigue; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Anxiety	Measure of anxiety; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Depression	Measure of depression; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Sleep Disturbance	Measure of sleep disturbance; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
PROMIS Satisfaction with Social Roles	Measure of satisfaction with social roles; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
Health status (Medical Outcome Study Short Form 12, version 2)	Measure of physical and mental health; Range 0 - 100; Population mean 50, standard deviation 10	at 6 and 12 weeks
Oswestry Disability Index (ODI)	Measure of pain-related disability; Range 0% - 100%; Scores greater than 30% indicative of moderate pain-related disability	at 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: North American Spine Society
• Investigators: Principal Investigator: Richard L Skolasky, ScD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Ketamine; Fentanyl; Gabapentin; Acetaminophen; Hydromorphone
• Other Study ID Numbers: IRB00113816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No