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

NCT02655523 | Withdrawn Phase 4

• 1 other identifier: STU00200460
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients Global Impression of Change (PIGC) questionnaire

  2 week interval for for up to 12 weeks

• Headache Under-Response to Treatment (HURT) questionnaire

  Baseline and 3 month

Study Arms (3)

Bupivacaine+Triamcinolone

ACTIVE COMPARATOR

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

Drug: Triamcinolone; Drug: Bupivacaine

Bupivacaine+Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone; Drug: Bupivacaine

Bupivacaine+Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline; Drug: Bupivacaine

Interventions

Triamcinolone DRUG

1 mL of 40 mg of Triamcinolone

Also known as: Kenalog

Bupivacaine+Triamcinolone

Dexamethasone DRUG

1 mL of 4mg of Dexamethasone

Also known as: Decadron

Bupivacaine+Dexamethasone

Normal Saline DRUG

1 mL of preservative free normal saline

Also known as: 0.9% sodium chloride

Bupivacaine+Saline

Bupivacaine DRUG

2 mL of 0.5% bupivacaine

Also known as: Sensorcaine

Bupivacaine+Dexamethasone; Bupivacaine+Saline; Bupivacaine+Triamcinolone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Feingberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Triamcinolone; Triamcinolone Acetonide; Dexamethasone; Calcium Dobesilate; Saline Solution; Sodium Chloride; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Antoun Nader, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)