Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials
Information source: Children's Hospital of Philadelphia
Information obtained from ClinicalTrials.gov on February 12, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trauma, Nervous System
Intervention: Intrathecal Morphine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s): Paul Stricker, MD, Principal Investigator, Affiliation: Children's Anesthesiology Associates
Overall contact: Paul Stricker, MD, Phone: 215-590-1876, Email: strickerp@email.chop.edu
Summary
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.
Clinical Details
Official title: Effects of Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials in Patients Undergoing Posterior Spine Fusion
Study design: Case Control, Prospective
Primary outcome: To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation
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
Minimum age: 11 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Intrathecal Morphine Group:
1. All patients with idiopathic scoliosis aged 11 through and including 18 who present to
CHOP for posterior spinal fusion will be eligible
2. Patients with procedures anticipated to extend to or below the second lumbar vertebral
level
3. Only patients given intrathecal morphine after curve correction and instrumentation
will be studied
Control Group:
1. All patients with idiopathic scoliosis aged 11 through and including 18 who present to
CHOP for posterior spinal fusion will be eligible
2. Patients with procedures not anticipated to extend to or below the second lumbar
vertebral level
3. Patients who do not receive IT morphine injection as part of their routine anesthetic
care
Exclusion Criteria:
Intrathecal Morphine Group:
1. Patients who receive inhaled anesthetic agents before or during the 30 minutes
following IT morphine injection
2. Patients who receive neuromuscular blocking drugs within an hour before or during the
30 minutes following IT morphine injection.
3. Patients who develop significant changes in TceMEPs prior to intrathecal morphine
injection
4. Patients with intraoperative hemodynamic instability which requires continuous
vasoactive drug infusion (e. g., dopamine)
5. Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
6. Pregnant or lactating females
Control Group:
1. Patients who receive inhaled anesthetic agents before or during the 30 minutes
following IT morphine injection
2. Patients who receive neuromuscular blocking drugs within an hour before or during the
30 minutes following IT morphine injection.
3. Patients who develop significant changes in TceMEPs prior to the study interval
4. Patients with intraoperative hemodynamic instability which requires continuous
vasoactive drug infusion (e. g., dopamine)
5. Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
6. Pregnant or lactating females
Locations and Contacts
Paul Stricker, MD, Phone: 215-590-1876, Email: strickerp@email.chop.edu
The Children's Hospital of Philadephia, Philadelphia, Pennsylvania 19104, United States; Recruiting Paul Stricker, MD, Principal Investigator
Additional Information
Starting date: August 2007
Ending date: July 2009
Last updated: January 15, 2009
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