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The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762109
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : December 3, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Spine Injury Drug: Dantrolene Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Dantrolene
muscle relaxant
Other Names:
  • Dantrium
  • Dantrolene Sodium

Placebo Comparator: 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.
Drug: Placebo Oral Tablet
inactive pill
Other Name: placebo




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Overall Benefit of Analgesia Score (OBAS) [ Time Frame: Measured at 48 hours after surgery ]
    OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).

  2. Richmond Agitation Sedation Scale (RASS) [ Time Frame: Measured at 24 and 48 hours after surgery ]
    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.

  3. Numerical Rating Scale (NRS) for Pain [ Time Frame: Measured at 0, 1, 2, 3, 24, 48 hours after surgery ]
    Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).

  4. ICU Length of Stay [ Time Frame: Until discharge from the hospital, on average 24 hours ]
    The length of the patients stay in the ICU will be measured in hours

  5. Hospital length of stay [ Time Frame: Until discharge from the hospital, on average three days ]
    The length of the patients stay in the hospital will be measured in days

  6. Benzodiazepine use postoperatively [ Time Frame: Until discharge from the hospital, on average three days ]
    The number of patients who receive benzodiazepines after surgery will be recorded.

  7. Morphine Equivalent Dose [ Time Frame: Duration of the patient's stay in the hospital, on average three days ]
    The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)

  8. ICU Mobility Score [ Time Frame: Measured at 24 and 48 hours after surgery ]
    The patients ability to move will be recorded on a scale from 0 (nothing, lying in bed; worst outcome) to 10 (walking independently without a gait aid; best outcome).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762109


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Richard J Pollard, MD Beth Israel Deaconess Medical Center
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03762109    
Other Study ID Numbers: 2018P000799
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Beth Israel Deaconess Medical Center:
Surgery
Dantrolene
Anesthesia
Additional relevant MeSH terms:
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Spinal Injuries
Back Injuries
Wounds and Injuries
Dantrolene
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents