0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment

NCT06937385 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 2024-302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.

Conditions

Headache; Migraine; Tension Headache; Occipital Neuralgia

Keywords

headache; bupivicaine; cervical injection; paraspinous injection

Outcome Measures

Primary Outcomes (1)

• Visual analog scale pain score 0-10

  Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.

  24 hours

Secondary Outcomes (2)

• Emergency department length of stay

  24 hours

• Need for additional medications

  24 hours

Study Arms (2)

Intravenous medication

ACTIVE COMPARATOR

physicians choice of intravenous medication for headache treatment

Drug: standard IV treatment for headache

cervical IM injection

EXPERIMENTAL

bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location

Drug: 0.5% Bupivacaine HCl

Interventions

0.5% Bupivacaine HCl DRUG

bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment

Also known as: cervical IM injection

cervical IM injection

standard IV treatment for headache DRUG

physicians choice of IV medications in treatment of headache

Intravenous medication

Eligibility Criteria

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

You may qualify if:

• Patient has to be able to provide own consent
• English-speaking only
• Non traumatic headache with VAS pain score of 5 or above out of 10

You may not qualify if:

• traumatic headache
• Confused patients
• allergy to bupivacaine
• infection over injection site
• recent neck surgery
• hemodynamically unstable
• bleeding disorder
• anticoagulation use
• pregnant, lactating women
• prisoners

Sponsors & Collaborators

• HCA Florida North Florida Hospital: lead

Study Sites (1)

HCA Florida north florida Hospital

Gainesville, Florida, 32605, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders; Tension-Type Headache

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Robyn Hoelle, MD

  HCA north florida hospital emergency department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhengqiu zhou, MD

CONTACT

8593686486; zhengqiu.zhou@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)