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

Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Headache; Occipital Neuralgia; Tension Headache
• Intervention / Treatment: Drug: standard IV treatment for headache; Drug: 0.5% Bupivacaine HCl

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: zhengqiu zhou, MD; Phone Number: 8593686486; Email: zhengqiu.zhou@icloud.com

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • HCA Florida North Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous medication; physicians choice of intravenous medication for headache treatment	Drug: standard IV treatment for headache; physicians choice of IV medications in treatment of headache
Experimental: cervical IM injection; bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location	Drug: 0.5% Bupivacaine HCl; bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment; Other Names: cervical IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency department length of stay	Duration that patients stayed in the Emergency department for	24 hours
Need for additional medications	Whether an additional medication was given to patients after 30 minutes	24 hours

Collaborators and Investigators

• Sponsor: HCA Florida North Florida Hospital
• Investigators: Principal Investigator: Robyn Hoelle, MD, HCA north florida hospital emergency department

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: bupivicaine; headache; cervical injection; paraspinous injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Headache; Neuralgia; Tension-Type Headache; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 2024-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will not be shared to protect patient safety and their healthcare information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No