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

NCT ID: NCT03088306

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-08-31

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.

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Spinal Instability; Lumbar Spine Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard analgesia use

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

Group Type: ACTIVE_COMPARATOR

Standard analgesia use [Oxygen]

Intervention Type: 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 [Hydromorphone]

Intervention Type: 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 [Volatile Anesthesia]

Intervention Type: 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 [Fentanyl]

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Multi-modal pain management [Acetaminophen + Gabapentin]

Intervention Type: 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 [Fentanyl]

Intervention Type: 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 [Intravenous Ketamine]

Intervention Type: 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 [Valium + Gabapentin]

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North American Spine Society

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Skolasky, ScD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00113816

Identifier Type: -

Identifier Source: org_study_id