A Comparison of Dexamethasone and Triamcinolone for Ultrasound-guided Occipital C2 Nerve Blocks

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Northwestern University

Status and phase

Withdrawn
Phase 4

Conditions

Headache

Treatments

Drug: Triamcinolone
Drug: Bupivacaine
Drug: Normal Saline
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT02655523
STU00200460

Details and patient eligibility

About

Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic procedure in headache patients. GON blocks have been shown to be effective in the treatment of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster headache, cervicogenic headache, and post-concussive headache. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar radicultis with great success. Dexamethasone is a water soluble steroid, when combined with local anesthetic; it may increase the analgesia of block duration relative to its pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a slower onset time but may provide anti-inflammatory effects up to several weeks. Investigators want to investigate to see if there exists a difference in reported pain intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with bupivacaine) which may provide a greater reduction in reported pain intensity relief may allow the patient to undergo fewer interventional procedures.

Full description

Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic procedure in headache patients. GON blocks have been shown to be effective in the treatment of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster headache, cervicogenic headache, and post-concussive headache.The GON provides sensory innervation to the posterior scalp to the vertex of the skull and is known to communicate with the third occipital nerve and lesser occipital nerve during its ascent at the occiput.The use of ultrasound guidance to assist with needle placement is becoming increasingly popular due to real-time visualization of soft tissue and surrounding vasculature as well as the appearance of bony structures. This imaging tool allows for fine adjustment of the needle tip and direct observation of the injectate thereby confirming local anesthetic spread at the targeted area. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar radicultis with great success. Dexamethasone is a water soluble steroid, when combined with local anesthetic; it may increase the analgesia of block duration relative to its pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a slower onset time but may provide anti-inflammatory effects up to several weeks. Investigators want to investigate to see if there exists a difference in reported pain intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with bupivacaine) which may provide a greater reduction in reported pain intensity relief may allow the patient to undergo fewer interventional procedures.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients, ≥ 18 years of age and under 75 years of age, presenting to the Northwestern Pain Center with occipital headaches who are scheduled to receive a ultrasound-guided occipital nerve block will be eligible for the study.
  • Extracranial tenderness or Tinel's sign over the occipital nerve
  • Poor response to other medical treatments (narcotics, physical therapy)
  • Paroxysmal stabbing pain, with or without persistent aching between paroxysms, in the distribution(s) of the greater, lesser and/or third occipital nerves
  • Visual Analog Scale (VAS) score of at least 4 at recent headache occurrence.

Exclusion criteria

  • Abnormal cranial anatomy
  • use of anticoagulants
  • local infection
  • refusal of or lack of consent
  • pregnant patients
  • systemic steroid in the last three months, steroid injection of any type in the last three months
  • inability to read
  • untreated/inadequately treated psychiatric disorders
  • cannot comprehend or complete the questionnaires
  • known allergies to local or steroids

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 3 patient groups, including a placebo group

Bupivacaine+Triamcinolone
Active Comparator group
Description:
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 40 mg of triamcinolone.
Treatment:
Drug: Bupivacaine
Drug: Triamcinolone
Bupivacaine+Dexamethasone
Active Comparator group
Description:
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 4 mg of dexamethasone.
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine
Bupivacaine+Saline
Placebo Comparator group
Description:
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL of preservative free normal saline.
Treatment:
Drug: Normal Saline
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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