The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Conditions
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Lumbar Spine Injury

Intervention / Treatment
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* Drug: Dantrolene
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dantrolene Group<br>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<br>* muscle relaxant<br>* Other names: Dantrolene Sodium;|
| Placebo Comparator: Placebo Oral Tablet Group<br>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<br>* inactive pill<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 0, 1, 2, 3, 24, 48 hours after surgery | 
| ICU Length of Stay | The length of the patients stay in the ICU will be measured in hours | Until discharge from the hospital, on average 24 hours | 
| 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 | 
| Morphine Equivalent Dose | The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams) | Duration of the patient's stay in 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 10 (walking independently without a gait aid; best outcome). | Measured at 24 and 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Dantrolene, Anesthesia