Trial Outcomes & Findings for The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery (NCT NCT03762109)
NCT ID: NCT03762109
Last Updated: 2026-06-18
Results Overview
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
Measured at 24 hours after surgery
Results posted on
2026-06-18
Participant Flow
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
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
45
|
52
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Persons that completed the study
Baseline characteristics by cohort
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 Mean Age in years
n=20 Participants • Persons that completed the study
|
64 Mean Age in years
n=20 Participants • Persons that completed the study
|
64 Mean Age in years
n=40 Participants • Persons that completed the study
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants • Persons that completed the study
|
20 Participants
n=20 Participants • Persons that completed the study
|
36 Participants
n=40 Participants • Persons that completed the study
|
|
Sex: Female, Male
Male
|
29 Participants
n=20 Participants • Persons that completed the study
|
32 Participants
n=20 Participants • Persons that completed the study
|
61 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Persons that completed the study
|
0 Participants
n=20 Participants • Persons that completed the study
|
0 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants • Persons that completed the study
|
0 Participants
n=20 Participants • Persons that completed the study
|
2 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Persons that completed the study
|
1 Participants
n=20 Participants • Persons that completed the study
|
1 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants • Persons that completed the study
|
2 Participants
n=20 Participants • Persons that completed the study
|
4 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
White
|
34 Participants
n=20 Participants • Persons that completed the study
|
44 Participants
n=20 Participants • Persons that completed the study
|
78 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants • Persons that completed the study
|
0 Participants
n=20 Participants • Persons that completed the study
|
0 Participants
n=40 Participants • Persons that completed the study
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=20 Participants • Persons that completed the study
|
5 Participants
n=20 Participants • Persons that completed the study
|
12 Participants
n=40 Participants • Persons that completed the study
|
PRIMARY outcome
Timeframe: Measured at 24 hours after surgeryPopulation: Participants that completed the study
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Overall Benefit of Analgesia Score (OBAS)
|
4.0 OBAS Score
Interval 2.0 to 6.0
|
4.0 OBAS Score
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Measured at 48 hours after surgeryPopulation: Participants that completed the study
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Overall Benefit of Analgesia Score (OBAS)
|
4 OBAS Score at 48 hours
Interval 2.0 to 6.0
|
4 OBAS Score at 48 hours
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Measured at 24 and 48 hours after surgeryPopulation: participants that completed the study
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.
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Richmond Agitation Sedation Scale (RASS)
24 Hours, Score of <0
|
2 Participants
|
6 Participants
|
|
Richmond Agitation Sedation Scale (RASS)
24 Hours, Score of >0
|
5 Participants
|
5 Participants
|
|
Richmond Agitation Sedation Scale (RASS)
48 Hours, Score of <0
|
2 Participants
|
6 Participants
|
|
Richmond Agitation Sedation Scale (RASS)
24 Hours, Score of 0
|
38 Participants
|
41 Participants
|
|
Richmond Agitation Sedation Scale (RASS)
48 Hours, Score of 0
|
38 Participants
|
41 Participants
|
|
Richmond Agitation Sedation Scale (RASS)
48 Hours, Score of >0
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Measured at 24, 48 hours after surgeryPain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Numerical Rating Scale (NRS) for Pain
24 Hours
|
6 score on a scale
Interval 4.0 to 8.0
|
6 score on a scale
Interval 3.75 to 8.0
|
|
Numerical Rating Scale (NRS) for Pain
48 hours
|
5 score on a scale
Interval 3.25 to 6.75
|
5 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Until discharge from the hospital, on average three daysPopulation: Hospital length of stay for all patients
The length of the patients stay in the hospital will be measured in days
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Hospital Length of Stay
|
4.00 days
Interval 3.0 to 5.0
|
4.50 days
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Until discharge from the hospital, on average three daysPopulation: Benzodiazepine use during hospital stay
The number of patients who receive benzodiazepines after surgery will be recorded.
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Benzodiazepine Use Postoperatively
Lorazepam
|
2 Participants
|
4 Participants
|
|
Benzodiazepine Use Postoperatively
Diazepam
|
22 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Measured at 24 and 48 hours after surgeryPopulation: participants that completed the study
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).
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
ICU Mobility Score
ICU Mobility Score at 24 Hours
|
7.00 score on a scale
Interval 0.0 to 9.0
|
2.00 score on a scale
Interval 0.0 to 9.0
|
|
ICU Mobility Score
ICU Mobility Score at 48 Hours
|
8.00 score on a scale
Interval 2.5 to 10.0
|
5.00 score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: During postoperative periodOME in mg at 24 and 48 hours
Outcome measures
| Measure |
Dantrolene Group
n=45 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Oral Morphine Eqivalent (OME) Doses
OME at 24 Hours
|
57.50 mg
Interval 45.0 to 74.5
|
57.50 mg
Interval 43.62 to 79.06
|
|
Oral Morphine Eqivalent (OME) Doses
OME at 48 Hours
|
45 mg
Interval 15.0 to 63.75
|
46.25 mg
Interval 26.25 to 75.0
|
Adverse Events
Dantrolene Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Oral Tablet Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dantrolene Group
n=45 participants at risk
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
|
Placebo Oral Tablet Group
n=52 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Surgical Complication
|
20.0%
9/45 • Number of events 9 • Last data collection (48 hours after surgery/baseline)
|
25.0%
13/52 • Number of events 13 • Last data collection (48 hours after surgery/baseline)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place