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

NCT ID: NCT06937385

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous medication

physicians choice of intravenous medication for headache treatment

Group Type: ACTIVE_COMPARATOR

standard IV treatment for headache

Intervention Type: DRUG

physicians choice of IV medications in treatment of headache

cervical IM injection

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

Group Type: EXPERIMENTAL

0.5% Bupivacaine HCl

Intervention Type: DRUG

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

Interventions

0.5% Bupivacaine HCl

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

Intervention Type: DRUG

standard IV treatment for headache

physicians choice of IV medications in treatment of headache

Intervention Type: DRUG

Other Intervention Names

cervical IM injection

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

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

Sponsors

HCA Florida North Florida Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhengqiu Zhou

Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robyn Hoelle, MD

Role: PRINCIPAL_INVESTIGATOR

HCA north florida hospital emergency department

Locations

HCA Florida north florida Hospital

Gainesville, Florida, United States

Countries

United States

Central Contacts

zhengqiu zhou, MD

Role: CONTACT

zhengqiu.zhou@icloud.com

8593686486

Other Identifiers

2024-302

Identifier Type: -

Identifier Source: org_study_id