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Muscle Relaxant

Dantrolene for Lower Back Injury

Phase 2
Recruiting
Led By Richard J Pollard, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 0, 1, 2, 3, 24, 48 hours after surgery
Awards & highlights

Study Summary

This trial will test whether a non-central nervous system muscle relaxant can help improve pain and sedation scores in patients undergoing lumbar fusion surgery.

Who is the study for?
This trial is for adults aged 18-80 who are having lumbar spine surgery under general anesthesia and can stay in the hospital. They should be healthy enough for surgery (ASA Category 1, 2, or 3) but not have severe liver, kidney, respiratory issues, heavy alcohol use, weigh over 140 kg, be pregnant/breastfeeding or have allergies to certain drugs.Check my eligibility
What is being tested?
The study tests if Dantrolene improves pain relief and calmness after lower back surgery compared to a placebo. Patients will receive either Dantrolene or a fake pill without knowing which one they get to see if there's a difference in their recovery scores.See study design
What are the potential side effects?
Dantrolene may cause side effects like muscle weakness, drowsiness, nausea or diarrhea. Since it's not acting on the brain directly, it might avoid some common side effects of other muscle relaxants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am scheduled for a lumbar spine surgery with less than 4 levels of fusion.
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My health is good to moderate, as rated by an anesthesiologist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the patient's stay in the hospital, on average three days
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the patient's stay in the hospital, on average three days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Benzodiazepine use postoperatively
Hospital length of stay
ICU Length of Stay
+5 more

Side effects data

From 2009 Phase 1 & 2 trial • 10 Patients • NCT00964548
20%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dantrolene (Low Dose)
Dantrolene (High Dose)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dantrolene GroupExperimental Treatment1 Intervention
Patients will receive 25 mg of Dantrolene orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
Group II: Placebo Oral Tablet GroupPlacebo Group1 Intervention
Patients will receive a 25 mg of a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dantrolene
2007
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,236 Total Patients Enrolled
Richard J Pollard, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Media Library

Dantrolene (Muscle Relaxant) Clinical Trial Eligibility Overview. Trial Name: NCT03762109 — Phase 2
Lower Back Injury Research Study Groups: Placebo Oral Tablet Group, Dantrolene Group
Lower Back Injury Clinical Trial 2023: Dantrolene Highlights & Side Effects. Trial Name: NCT03762109 — Phase 2
Dantrolene (Muscle Relaxant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03762109 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks come with the consumption of Dantrolene?

"Our team at Power has assigned Dantrolene a rating of 2 on the 1-3 scale, owing to its Phase 2 status. Though there is some evidence demonstrating safety, efficacy data remains unavailable."

Answered by AI

What have been the recorded outcomes of other investigations involving Dantrolene?

"At this moment, 5 clinical trials for Dantrolene are underway. A single study has progressed to the third phase of testing while the rest are in earlier stages. The majority of these tests can be found near Saint Louis, Missouri but there are also 6 other sites running related experiments."

Answered by AI

To what medical maladies is Dantrolene commonly prescribed?

"Dantrolene is typically prescribed for the management of cerebrovascular accident and has been documented to effectively treat spinal cord trauma, malignant hyperthermia, as well as spasticity."

Answered by AI

Are enrollment opportunities still open for this clinical experiment?

"Affirmative. Clinicaltrials.gov's records indicate that this clinical trial, which was initially published on July 29th 2019, is actively seeking participants. The study requires the recruitment of one hundred patients from a single site."

Answered by AI

Who is eligible to take part in this experiment?

"Eligible candidates should have suffered spinal injuries and be between 18 to 80 years of age. This medical experiment is recruiting a total of 100 patients."

Answered by AI

Is this research taking into account the participation of individuals aged 45 or over?

"As per the trial's prerequisites, potential participants need to be aged between 18 and 80."

Answered by AI

How many participants is the research team currently recruiting for this trial?

"Affirmative. According to the information from clinicaltrials.gov, this research protocol was posted on July 29th 2019 and is actively recruiting participants at present time. The study requires 100 individuals across a single medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Richard J. Pollard 2019. "The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03762109.
~18 spots leftby Apr 2025
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