Spine surgery pain relief: which Add-On works best?
NCT ID NCT06898697
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
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100 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Dec 2025
- Lead sponsor
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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
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21 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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