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

Headache Clinical Trial

Official title:

A Comparison of Dexamethasone and Triamcinolone in Combination With Bupivacaine for Ultrasound-guided Occipital C2 Nerve Blocks: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02655523
• Other study ID #: STU00200460
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Triamcinolone
1 mL of 40 mg of Triamcinolone
• Dexamethasone
1 mL of 4mg of Dexamethasone
• Normal Saline
1 mL of preservative free normal saline
• Bupivacaine
2 mL of 0.5% bupivacaine

Locations

Country	Name	City	State
United States	Northwestern University, Feingberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS (Patient Reported Outcome Measurement Information System) Pain Intensity Questionnaire	Area under the PROMIS Pain Intensity Questionnaire T-score versus time profile for the 12 week study period	2 weeks interval for up to 12 weeks
Secondary	Patients Global Impression of Change (PIGC) questionnaire	The Patient Global Impression of Change (PGIC) is a 7-point scale depicting a patient's rating of overall improvement.	2 week interval for for up to 12 weeks
Secondary	Headache Under-Response to Treatment (HURT) questionnaire	The HURT Questionnaire consists of eight questions which the patient answers as a measure of effectiveness of intervention against headache.	Baseline and 3 month