Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials

NCT00596609 | Completed

• 1 other identifier: 2007-4-5176
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma, Nervous System

Keywords

Injections, intrathecal; Transcranial; Spinal Fusion; Evoked Potentials, Motor

Outcome Measures

Primary Outcomes (1)

• To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation

  30 minute period - Group 1 - after IT morphine injection or during skin closure for Group 2.

Study Arms (2)

1

Group 1 will be subjects who receive Intrathecal Morphine.

Drug: Intrathecal Morphine

2

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

Interventions

Intrathecal Morphine DRUG

* 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.

1

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadephia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Trauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries

Study Officials

• Paul Stricker, MD

  Children's Anesthesiology Associates, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 17, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

US (1)