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Clinical Trials/NCT00613340
NCT00613340CompletedNot Applicable

Randomized Study Comparing the Accuracy and Specificity of Cervical Facet Medial Branch Blocks With 0.25 ml and 0.5 ml of Local Anesthetic

Johns Hopkins University1 site in 1 country20 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Accuracy of injections

Study Overview

Brief Summary

Cervical facet arthropathy is a common cause of chronic neck pain. The "gold standard" for diagnosis is either blocking the facet joints, or more commonly blocking the medial branch nerves that innervate the joints. However, many studies have found a high false-positive rate when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for the high false-positive rate.

Detailed Description

Inclusion criteria: Dept. of Defense beneficiaries > 18 years of age; neck pain > 3 months duration; cervical paraspinal tenderness Exclusion criteria: Radicular signs or symptoms; use of anticoagulants or bleeding disorder.

Outcome measures: The number of blocks whereby the contrast bathes the target nerve; the number of blocks whereby the contrast spreads to the medial branch nerve at the adjacent spinal level; the number of times the contrast diffuses into the intervertebral foramen or epidural space. We will also compare pain relief over 8 hours following the block between both volumes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age > 18 years
  • •Chronic neck pain > 3 months
  • •Paraspinal tenderness

Exclusion Criteria

  • •Absence of radicular symptoms
  • •No bleeding diathesis
  • •Contrast allergy

Arms & Interventions

1

Experimental

Cervical medial branch blocks with 0.25 ml of injectate

Intervention: Cervical medial branch blocks (Procedure)

2

Experimental

Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast

Intervention: Cervical medial branch blocks (Procedure)

Outcomes

Primary Outcomes

Accuracy of injections

Time Frame: Immediately after nerve blocks.

Secondary Outcomes

  • Pain relief after nerve blocks(8 hours after blocks)

Investigators

Sponsor Class
Other

Study Sites (1)

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