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

NCT ID: NCT02655523

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivacaine+Triamcinolone

An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 40 mg of triamcinolone.

Group Type: ACTIVE_COMPARATOR

Triamcinolone

Intervention Type: DRUG

1 mL of 40 mg of Triamcinolone

Bupivacaine

Intervention Type: DRUG

2 mL of 0.5% bupivacaine

Bupivacaine+Dexamethasone

An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 4 mg of dexamethasone.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

1 mL of 4mg of Dexamethasone

Bupivacaine

Intervention Type: DRUG

2 mL of 0.5% bupivacaine

Bupivacaine+Saline

An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL of preservative free normal saline.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

1 mL of preservative free normal saline

Bupivacaine

Intervention Type: DRUG

2 mL of 0.5% bupivacaine

Interventions

Triamcinolone

1 mL of 40 mg of Triamcinolone

Intervention Type: DRUG

Dexamethasone

1 mL of 4mg of Dexamethasone

Intervention Type: DRUG

Normal Saline

1 mL of preservative free normal saline

Intervention Type: DRUG

Bupivacaine

2 mL of 0.5% bupivacaine

Intervention Type: DRUG

Other Intervention Names

Kenalog; Decadron; 0.9% sodium chloride; Sensorcaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Antoun Nader

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoun Nader, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern University, Feingberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00200460

Identifier Type: -

Identifier Source: org_study_id