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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dantrolene | Drug | muscle relaxant |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). | Measured at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). | Measured at 48 hours after surgery |
| Richmond Agitation Sedation Scale (RASS) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Pollard, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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Randomization was performed prior to surgery using a computer-generated randomization scheme prepared by an unblinded statistician and implemented by the research pharmacy. The pharmacy prepared and dispensed identical-appearing study medications to maintain blinding. Participants, clinicians, and all study personnel involved in data collection and outcome assessment were blinded to treatment assignment.
Participants were eligible for enrollment if they met all the following criteria:
Age 18 to 80 years, inclusive. Scheduled to undergo lumbar spine decompression and/or instrumented fusion involving two or more vertebral levels via a posterior surgical approach under general anesthesia at Beth Israel Deaconess Medical Center.
Planned same-day admission or inpatient hospital admission following surgery. Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
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| ID | Title | Description |
|---|---|---|
| FG000 | Dantrolene Group | 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. |
| FG001 | Placebo Oral Tablet Group | Patients will receive a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants that completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Dantrolene Group | 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. |
| BG001 | Placebo Oral Tablet Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Average age of participants that completed the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Benefit of Analgesia Score (OBAS) | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). | Participants that completed the study | Posted | Mean | Inter-Quartile Range | OBAS Score | Measured at 24 hours after surgery |
|
Last data collection (48 hours after surgery/baseline)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dantrolene Group | 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. Dantrolene: muscle relaxant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Complication | Nervous system disorders | SNOMED CT | Systematic Assessment | Adverse event reported that is not associated with anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard J Pollard | BIDMC | 6176675501 | rpollard@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2023 | Feb 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003620 | Dantrolene |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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| Placebo Oral Tablet | Drug | inactive pill |
|
|
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 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 at 24, 48 hours after surgery |
| Hospital Length of Stay | The length of the patients stay in the hospital will be measured in days | Until discharge from the hospital, on average three days |
| Benzodiazepine Use Postoperatively | The number of patients who receive benzodiazepines after surgery will be recorded. | 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 at 24 and 48 hours after surgery |
| Oral Morphine Eqivalent (OME) Doses | OME in mg at 24 and 48 hours | During postoperative period |
Patients will receive a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
| BG002 | Total | Total of all reporting groups |
Persons that completed the study
| Mean |
| Inter-Quartile Range |
| Mean Age in years |
|
| Sex: Female, Male | Persons that completed the study | Count of Participants | Participants |
|
| Race (NIH/OMB) | Persons that completed the study | Count of Participants | Participants |
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|
|
| Secondary | Overall Benefit of Analgesia Score (OBAS) | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). | Participants that completed the study | Posted | Mean | Inter-Quartile Range | OBAS Score at 48 hours | Measured at 48 hours after surgery |
|
|
|
| Secondary | 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. | participants that completed the study | Posted | Count of Participants | Participants | Measured at 24 and 48 hours after surgery |
|
|
|
| Secondary | Numerical Rating Scale (NRS) for Pain | Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). | Posted | Mean | Inter-Quartile Range | score on a scale | Measured at 24, 48 hours after surgery |
|
|
|
| Secondary | Hospital Length of Stay | The length of the patients stay in the hospital will be measured in days | Hospital length of stay for all patients | Posted | Median | Inter-Quartile Range | days | Until discharge from the hospital, on average three days |
|
|
|
| Secondary | Benzodiazepine Use Postoperatively | The number of patients who receive benzodiazepines after surgery will be recorded. | Benzodiazepine use during hospital stay | Posted | Count of Participants | Participants | Until discharge from the hospital, on average three days |
|
|
|
| Secondary | 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). | participants that completed the study | Posted | Median | Inter-Quartile Range | score on a scale | Measured at 24 and 48 hours after surgery |
|
|
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| Secondary | Oral Morphine Eqivalent (OME) Doses | OME in mg at 24 and 48 hours | Posted | Median | Inter-Quartile Range | mg | During postoperative period |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 9 |
| 45 |
| EG001 | Placebo Oral Tablet Group | 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. Placebo Oral Tablet: inactive pill | 0 | 52 | 0 | 52 | 13 | 52 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 24 Hours, Score of >0 |
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| 48 Hours, Score of <0 |
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| 48 Hours, Score of 0 |
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| 48 Hours, Score of >0 |
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