Cervical Epidural Pressure Measurement

Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions

Cervical epidural steroid injections

• The hanging drop (HD) technique is commonly used for identifying the cervical epidural space.
• The hanging drop (HD) technique is using the negative pressure in the epidural space.
• The subject of debate whether the epidural space exhibits negative pressure.
• In a previous study, EP might be influenced by body position
• No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.

The hypothesis of this study

• There is a difference in the cervical epidural pressure between in the prone and sitting positions
• To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
• Using a closed pressure measurement system
• Under fluoroscopic guidance.

Study Overview

• Status: Unknown
• Conditions: Neck Pain; Head Pain; Upper Extremity Pain
• Intervention / Treatment: Procedure: cervical epidural steroid injection; Procedure: epidural pressure measurement

Detailed Description

Cervical epidural steroid injections (CESIs)

• For the conservative management of head, neck, and upper extremity pain
• Important to identify the epidural space for minimizing the chance of a dural puncture injection
• Dural puncture injection makes CESIs prone to rare but catastrophic complication like permanent spinal cord injury

The hanging drop (HD) technique

• Commonly used for identifying the cervical epidural space
• Using the negative pressure in the epidural space
• The subject of debate whether the epidural space exhibits negative pressure

In previous studies using a closed pressure measurement systems

• The epidural pressure (EP) was commonly positive at the thoracic level in the lateral decubitus position.
• EP was consistently negative only in the sitting position.
• EP might be influenced by body position.
• The patient should be sitting for using the HD technique.

No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.

The hypothesis of this study

• There is a difference in the cervical epidural pressure between in the prone and sitting positions
• To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
• Using a closed pressure measurement system
• Under fluoroscopic guidance.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyonggi-do
    • Kumi, Kyonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• cervical radicular pain caused by herniated nucleus pulpous and spinal stenosis
• other conditions including herpes zoster-associated pain and sprain.

Exclusion Criteria:

• contraindications for CESIs, such as coagulopathy, patient refusal or infection at the proposed insertion site
• previous cervical spinal surgery
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prone position	Procedure: cervical epidural steroid injection; After aseptic preparation and skin infiltration with 1% lidocaine; 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level; identification of the epidural space confirmed by injection of contrast medium under fluoroscope; injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl).; Post-procedure, patients were observed for any adverse effects and followed with a neurological examination; Other Names: cervical interlaminar epidural injection; Procedure: epidural pressure measurement; The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view.; Identification of the epidural space and measurement of EP was performed with a closed measurement system.; Other Names: a closed pressure measurement system
Active Comparator: sitting position	Procedure: cervical epidural steroid injection; After aseptic preparation and skin infiltration with 1% lidocaine; 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level; identification of the epidural space confirmed by injection of contrast medium under fluoroscope; injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl).; Post-procedure, patients were observed for any adverse effects and followed with a neurological examination; Other Names: cervical interlaminar epidural injection; Procedure: epidural pressure measurement; The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view.; Identification of the epidural space and measurement of EP was performed with a closed measurement system.; Other Names: a closed pressure measurement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cervical epidural pressure	on interventional procedure (cervical epidural steroid injetion)

Secondary Outcome Measures

Outcome Measure	Time Frame
the angle of the neck flexion	on interventional procedure (cervical epidural steroid injection)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jeeyoun Moon, Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Joo Y, Moon JY, Kim YC, Lee SC, Kim HY, Park SY. A pressure comparison between midline and paramedian approaches to the cervical epidural space. Pain Physician. 2014 Mar-Apr;17(2):155-62.
• Moon JY, Lee PB, Nahm FS, Kim YC, Choi JB. Cervical epidural pressure measurement: comparison in the prone and sitting positions. Anesthesiology. 2010 Sep;113(3):666-71. doi: 10.1097/ALN.0b013e3181e898e8.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): November 1, 2009
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: November 4, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 6, 2009
• Last Update Submitted That Met QC Criteria: November 5, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: epidural; monitoring; cervical; epidural pressure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Headache
• Other Study ID Numbers: snu23802