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NCT07116408 · ClinicalTrials.gov registry record · Phase 4

Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

A Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Wright State University.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT07116408: Recruiting Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Wright State University.

NCT07116408 is a Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH) that is actively recruiting participants, run by Wright State University. The registered enrollment target is 20 participants, below the 155-participant average among 35 other Headache trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07116408, a Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH), is actively recruiting participants, sponsored by Wright State University.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat. The use of standard pain medications is common, but pain control remains poor. Additionally, pain medicines have multiple side effects including sedation, interference with breathing, intestinal cramping, low blood pressure, and the risk of addiction. In the present study, the investigators will examine the use of a medication to block the sphenopalatine ganglion which is a bundle of nerves that includes nerves that cause head pain. This block is performed by spraying numbing medication into the back of the nasal cavity on both sides. This particular pain medication does not have the side effects discussed above. The purpose of the study is to see if this treatment will decrease pain without causing unwanted side effects. All patients in the study will receive standard pain medicine as needed for headache. Information will be collected from the patient's medical chart on the amount of pain medication used and the amount of pain the patient describes having. The average pain will be calculated for the first 24 hours the patient is in the hospital. At that point, the patient will receive pain medication sprayed into the back of the nasal cavity on both sides. Patients will also receive this treatment 3 days later. Following these treatments, information will be obtained on the average amount of pain, and how much other pain medication is used. The investigators will look at the amount of pain and the amount of other pain medicine used over the first 24 hours before the nasal pain medicine treatment and compare it to the time after the treatments to see if the amount of pain decreases and if the amount of other pain medicine needed decreases as well. Six months after discharge, the patient will be contacted by phone to find out more information about how much head pain they had after discharge from the hospital.

Primary Outcome

Description of headache severity using the headache numerical rating scale. The scale is a subjective rating of headache pain. The scale ranges from 0-10 with 0 being no pain (minimum value, better outcome) and 10 being the worst pain imaginable (maximum value, worse outcome).

Interventions

  • DRUG Lidocaine (drug)
  • DEVICE Tx 360

Study Locations (1)

Ohio

  • Miami Valley Hospital - Dayton

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-05-20
Est. Completion 2027-05
Phase Phase 4
Wright State University

32 total trials

What NCT07116408 shows while recruiting

NCT07116408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 155-participant average among 35 other Headache trials with a reported enrollment target (87% lower).

The record links to 2 conditions, with Headache appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine (drug) is the first listed.

NCT07116408 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT07116408 about?

NCT07116408 is a clinical study titled "Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage". In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat. The use of standard pain medications is common, but pain control remains poor. Additionally, pain medicines have multiple side effects including sedation, interfere...

What is the current status of trial NCT07116408?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-05-20. Estimated completion is 2027-05.

What conditions does trial NCT07116408 study?

This clinical trial studies the following conditions: Headache, Aneurysmal Subarachnoid Hemorrhage (aSAH).

What interventions are being tested in trial NCT07116408?

The interventions under investigation include: Lidocaine (drug) (DRUG), Tx 360 (DEVICE).

Who is sponsoring clinical trial NCT07116408?

This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07116408 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Headache

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07116408's enrollment target sits among peer trials

20 32nd of 35 higher than 2 of 35 other Headache trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Headache trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07116408, the US trial registry maintained by the National Library of Medicine. NCT07116408 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.