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New drug combo aims to stop spinal headaches before they start

NCT ID NCT07528118

Prevention Sponsor: Sargodha Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two drug combinations to prevent post-dural puncture headache (PDPH) in 50 surgical patients who had experienced PDPH before. One group received aminophylline plus acetaminophen, and the other received aminophylline plus dexamethasone. The goal was to see which combination better reduced the chance and severity of headache after spinal anesthesia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aminophylline, Acetaminophen, Dexamethasone
What this could lead to
If successful, this could point toward a reliable way to prevent post-dural puncture headaches in people who have had them before.
What could go wrong
This is a small, early-phase study with only 50 participants, so results may not apply to everyone. The drugs also have potential side effects like allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients from 18-40 years. * Elective surgery under spinal anesthesia * Those patients having history of PDPH * BMI≤ 35kg/m2 * American Society of Anesthesiologist (ASA) Physical Status I and II Exclusion Criteria: * History of known allergy or hypersensitivity against study drug * Emergency surgery * Obstetric patient * Failed spinal * Multiple attempts of spinal * Contraindication to Spinal Anesthesia * Chronic disease patients already taking opioids or NSAIDs * History of migraine or other headaches * Partially effective spinal anesthesia * Abnormal liver or kidney function, cardiovascular system diseases, respiratory system diseases and diseases of the nervous system * Intraoperative blood loss \>1000ml * Intraoperative hemodynamic instability

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Conditions

The condition(s) this trial relates to.

Post-Dural Puncture Headache intracranial hypotension prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-dural puncture headache

Contacts and locations

Locations

  • Dr.Faisal Masood Teaching Hospital, Sargodha

    Sargodha, Punjab Province, 40100, Pakistan

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