Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials - Full Text View

Sponsor:	Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00596609

Purpose

Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical correction of the abnormal spinal curvature. The degree of neurologic injury can range from minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to identify impending neurologic injury. These consultants monitor spinal cord pathways by recording and analyzing evoked potentials during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory neural pathways.

Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most commonly used anesthetic agents have well-characterized effects on evoked potentials, little data exists on the effects of IT morphine on transcranial electric motor-evoked potentials (TceMEPs).

This is a prospective observational study to characterize the effects of IT morphine on TceMEPs.

Condition	Intervention
Trauma, Nervous System	Drug: Intrathecal Morphine

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Effects of Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials in Patients Undergoing Posterior Spine Fusion

Resource links provided by NLM:

MedlinePlus related topics: Injuries Surgery Wounds

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation [ Time Frame: 30 minute period - Group 1 - after IT morphine injection or during skin closure for Group 2. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	36
Study Start Date:	August 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Group 1 will be subjects who receive Intrathecal Morphine.	Drug: Intrathecal Morphine In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled "Baseline." These will serve as controls for subsequent recording comparisons. In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection.
2 Group 2 will be subjects who do not receive Intrathecal Morphine.

Groups/Cohorts

Assigned Interventions

1

Group 1 will be subjects who receive Intrathecal Morphine.

Drug: Intrathecal Morphine

In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled "Baseline." These will serve as controls for subsequent recording comparisons.
In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection.

2

Group 2 will be subjects who do not receive Intrathecal Morphine.

Detailed Description:

Posterior spinal fusion surgery (PSF) is associated with significant postoperative pain. Numerous postoperative pain management strategies have been employed for patients undergoing these procedures, including continuous narcotic infusions, intravenous patient-controlled opioid analgesia, epidural analgesia, intrathecally administered narcotics, and combinations of these regimens. Most patients at CHOP have their pain managed with intravenous patient-controlled opioid analgesia alone or in combination with a single dose of intra-operatively administered intrathecal (IT) morphine.

Patients undergoing spinal fusion procedures are also at risk for perioperative neurologic injury. Surgeons at CHOP and other institutions routinely utilize neurophysiologists to evaluate at-risk neural pathways to identify impending spinal cord and spinal nerve root injury. These consultants monitor motor and sensory pathways by recording and analyzing evoked potentials and electromyography during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory nerves.

At CHOP, IT morphine is injected by the surgeon after the scoliotic curvature has been corrected and spinal instrumentation is complete. This injection therefore occurs after the critical period for neurophysiologic monitoring and risk of spinal cord injury. It is injected after the neurophysiologist has given a reassuring assessment of neural integrity. This injection is given to patients who have spinal fusions extending below the second lumbar vertebral body. Injections are limited to this group of patients because the appropriate intervertebral spaces for intrathecal injection are not exposed in procedures that do not extend below this level.

Most commonly used anesthetic agents have well-characterized effects on evoked potentials. The effects of IT morphine on sensory-evoked potentials have been studied. However, little data exist on its effects on transcranial electric motor-evoked potentials. This study aims to characterize these effects; we hypothesize that intrathecal morphine has no effect on transcranial electric motor-evoked potentials in the doses used at our institution.

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children ages 11-18 with idiopathic scoliosis who are scheduled to have a posterior spinal fusion.

Criteria

Inclusion Criteria:

Intrathecal Morphine Group:

All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
Patients with procedures anticipated to extend to or below the second lumbar vertebral level
Only patients given intrathecal morphine after curve correction and instrumentation will be studied

Control Group:

All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
Patients with procedures not anticipated to extend to or below the second lumbar vertebral level
Patients who do not receive IT morphine injection as part of their routine anesthetic care

Exclusion Criteria:

Intrathecal Morphine Group:

Patients who receive inhaled anesthetic agents before or during the 30 minutes following IT morphine injection
Patients who receive neuromuscular blocking drugs within an hour before or during the 30 minutes following IT morphine injection.
Patients who develop significant changes in TceMEPs prior to intrathecal morphine injection
Patients with intraoperative hemodynamic instability which requires continuous vasoactive drug infusion (e.g., dopamine)
Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
Pregnant or lactating females

Control Group:

Patients who receive inhaled anesthetic agents before or during the 30 minutes following IT morphine injection
Patients who receive neuromuscular blocking drugs within an hour before or during the 30 minutes following IT morphine injection.
Patients who develop significant changes in TceMEPs prior to the study interval
Patients with intraoperative hemodynamic instability which requires continuous vasoactive drug infusion (e.g., dopamine)
Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596609

Locations

United States, Pennsylvania
The Children's Hospital of Philadephia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator:

Paul Stricker, MD

Children's Anesthesiology Associates, Ltd.

More Information

No publications provided

Responsible Party:	Children's Anesthesiology Associates ( Paul Stricker, MD )
Study ID Numbers:	2007-4-5176
Study First Received:	January 9, 2008
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00596609 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Injections, intrathecal
Transcranial
Spinal Fusion
Evoked Potentials, Motor

Additional relevant MeSH terms:

Morphine
Nervous System Diseases
Physiological Effects of Drugs
Wounds and Injuries
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Trauma, Nervous System

Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010