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Spine surgery pain relief: which Add-On works best?

NCT ID NCT06898697

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding midazolam or fentanyl to a standard epidural painkiller (bupivacaine plus dexamethasone) improves pain control after lumbar spine fixation surgery. One hundred adults undergoing elective surgery were randomly assigned to receive one of the two add-ons. The main goal was to see how long it took before patients needed extra pain medication, with secondary measures including pain scores, total opioid use, and hospital stay length.

What this could mean

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

Active substance
midazolam and fentanyl
What this could lead to
If successful, this could show that adding midazolam to standard epidural painkillers provides longer-lasting pain relief after spine surgery, reducing the need for additional opioids.
What could go wrong
This is a small, single-center study with only 100 participants. The results may not apply to all patients or surgeries, and both midazolam and fentanyl carry risks like sedation or breathing problems.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Apr 2025

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

21 to 64 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: * Written informed consent from the patient. * Physical status: ASA 1\& II. * BMI = (25-30 kg/m2). * Type of operation: elective lumbar spine Fixation. Exclusion Criteria: * Altered mental state. * Patients with known history of allergy to study drugs. * Advanced hepatic, renal, cardiovascular, and respiratory diseases. * Patients with chronic pain. * Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Faculty of Medicine,Zagazig University

    Zagazig, 44519, Egypt

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