Lumbar Spine InjuryPhase 2NCT03762109

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

A Phase 2 study testing Dantrolene in people with Lumbar Spine Injury, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lumbar Spine Injury
What is being tested?: Dantrolene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 29 Jul 2019to 1 Jun 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

History of obstructive sleep apnea
Weight > 140 kg
Currently pregnant
Actively breastfeeding
Inability to provide written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Conditions: Lumbar Spine Injury
Being tested: Dantrolene, Placebo Oral Tablet
Keywords: Surgery, Dantrolene, Anesthesia
Medical subject headings: Spinal Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DantroleneDrug
Also called Dantrium, Dantrolene Sodium
muscle relaxant
Placebo Oral TabletDrug
Also called placebo
inactive pill

Study groups in NCT03762109
Study group	Role	What they receive
Dantrolene Group	Experimental	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. Receives: Drug: Dantrolene
Placebo Oral Tablet Group	Placebo comparator	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. Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Measured: Measured at 24 hours after surgery

Secondary outcomes (7)

Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Measured: Measured at 48 hours after surgery
Richmond Agitation Sedation Scale (RASS)
The Richmond Agitation and Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the intensive care unit. Scores range from +4 (combative) to -5 (unarousable). A score of 0 (alert and calm) is considered the best outcome.
Measured: Measured at 24 and 48 hours after surgery
Numerical Rating Scale (NRS) for Pain
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Measured: Measured at 24, 48 hours after surgery
Hospital Length of Stay
The length of the patients stay in the hospital will be measured in days
Measured: Until discharge from the hospital, on average three days
Benzodiazepine Use Postoperatively
The number of patients who receive benzodiazepines after surgery will be recorded.
Measured: Until discharge from the hospital, on average three days
ICU Mobility Score
The patients ability to move will be recorded on a scale from 0 (nothing, lying in bed; worst outcome) to 20 (walking independently without a gait aid; best outcome).
Measured: Measured at 24 and 48 hours after surgery
Oral Morphine Eqivalent (OME) Doses
OME in mg at 24 and 48 hours
Measured: During postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 20191 Jun 2024

First posted3 Dec 2018
Study start29 Jul 2019
Primary completion1 Jun 2024
Study completion1 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Spine InjuryStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03762109
Sponsor's protocol ID: 2018P000799
Status last verified: Jun 2026
First submitted: 30 Nov 2018
Last updated: 18 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery
Postoperative Pain After Spinal Surgery
Recruiting
3D Printing in Preoperative Planning in Thoracic and Lumbar Spine Trauma
Spine Trauma (Thoracic and Lumbar)
Active, not recruiting
Non-surgical Spinal Decompression Therapy and Outcomes
Low Back Pain, Herniation, Disc
Active, not recruitingObservational study
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
Pseudarthrosis After Fusion or Arthrodesis
Not yet recruiting
Occupational Exposure to Whole Body Vibration Among U.S. Military Veterans: Acute and Chronic Contributions to Musculoskeletal Disorders and Spine-Area Pain
Spine Health, Spine Injuries and Disorders

All Lumbar Spine Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
ClinicalTrials.gov ID: NCT03762109
Acronym / sponsor ID: 2018P000799
Conditions: Lumbar Spine Injury
Keywords: Surgery, Dantrolene, Anesthesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Study start: 29 Jul 2019 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 3 Dec 2018 (actual)
Results: Posted 18 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Dantrolene Group	Experimental	Drug: DantrolenePatients 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.
Placebo Oral Tablet Group	Placebo comparator	Drug: Placebo Oral TabletPatients 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DantroleneAlso: Dantrium, Dantrolene Sodiummuscle relaxant	Drug	Dantrolene Group
Placebo Oral TabletAlso: placeboinactive pill	Drug	Placebo Oral Tablet Group

Primary outcome

Overall Benefit of Analgesia Score (OBAS)
Time frame: Measured at 24 hours after surgery
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).

7 secondary outcomes

Overall Benefit of Analgesia Score (OBAS)
Time frame: Measured at 48 hours after surgery
Richmond Agitation Sedation Scale (RASS)
Time frame: Measured at 24 and 48 hours after surgery
Numerical Rating Scale (NRS) for Pain
Time frame: Measured at 24, 48 hours after surgery
Hospital Length of Stay
Time frame: Until discharge from the hospital, on average three days
Benzodiazepine Use Postoperatively
Time frame: Until discharge from the hospital, on average three days
ICU Mobility Score
Time frame: Measured at 24 and 48 hours after surgery
Oral Morphine Eqivalent (OME) Doses
Time frame: During postoperative period

Results and safety

Results posted to the registry on 18 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dantrolene Group	58	45
Placebo Oral Tablet Group	58	52

Primary outcome: Overall Benefit of Analgesia Score (OBAS)

Time frame: Measured at 24 hours after surgery. Mean (Inter-Quartile Range). Unit: OBAS Score

Measure	Dantrolene Group n = 45	Placebo Oral Tablet Group n = 52
Value	4.0 (2 to 6)	4.0 (2 to 6)

Population analysed: Participants that completed the study

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Last data collection (48 hours after surgery/baseline). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dantrolene Group	0 of 45 (0%)	9 of 45 (20%)	0 of 45
Placebo Oral Tablet Group	0 of 52 (0%)	13 of 52 (25%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lumbar Spine Injury

Enrolling by invitationPhase 4
Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery
Postoperative Pain After Spinal Surgery
Recruiting
3D Printing in Preoperative Planning in Thoracic and Lumbar Spine Trauma
Spine Trauma (Thoracic and Lumbar)
Active, not recruiting
Non-surgical Spinal Decompression Therapy and Outcomes
Low Back Pain, Herniation, Disc
Active, not recruitingObservational study
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
Pseudarthrosis After Fusion or Arthrodesis
Not yet recruiting
Occupational Exposure to Whole Body Vibration Among U.S. Military Veterans: Acute and Chronic Contributions to Musculoskeletal Disorders and Spine-Area Pain
Spine Health, Spine Injuries and Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard J Pollard, MD principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dantrolene in people with Lumbar Spine Injury, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Benefit of Analgesia Score (OBAS) (time frame: Measured at 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.