Could a muscle relaxant make back surgery recovery less painful?
NCT ID NCT03762109
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether dantrolene, a non-sedating muscle relaxant, can improve pain control and reduce agitation in adults undergoing lumbar fusion surgery. Participants receive either dantrolene or a placebo pill before and after surgery. The goal is to see if dantrolene improves overall pain relief and sedation levels compared to standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dantrolene (a muscle relaxant)
- What this could lead to
- If it works, this could offer a better way to manage pain after back surgery without relying solely on opioids.
- What could go wrong
- This is a small, early-phase study, so results may not apply to everyone. Dantrolene can cause muscle weakness or liver issues in rare cases.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
116 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jun 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 80 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 Hide 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 * 18 - 80 years of age (inclusive) * Presenting to the study hospital for lumbar decompression and/or fusion (instrumented fusion of the lumbar spine \< 4 levels) under general anesthesia, and scheduled for same-day admission or in-patient admission * American Society of Anesthesiologists (ASA) Category 1, 2 or 3 Exclusion Criteria * Known allergy to Dantrolene, morphine or other opioids, benzodiazepines that causes a reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters, irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness, drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or nephritis * Oxygen saturation \< 94% * Patient being treated with any of the following medications:Non-dihydropyridine Calcium Channel Blockers including verapamil, Estrogen therapy * Current or past medical history of any of the following: hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic hypoxia or hypercapnia, COPD) * Recent history of aspiration (within the last 3 months) * Patients with any history of neuromuscular dysfunction * History of obstructive sleep apnea * Weight \> 140 kg * Currently pregnant * Actively breastfeeding * Inability to provide written informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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