The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 30, 2023

Interventions

  • Drug: Dantrolene
    • muscle relaxant
  • Drug: Placebo Oral Tablet
    • inactive pill

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • 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.
  • 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).
  • 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
  • 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
  • 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.
  • 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)
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard J. Pollard, Director, Neurosurgical Anesthesia Fellowship – Beth Israel Deaconess Medical Center
  • Overall Official(s)
    • Richard J Pollard, MD, Principal Investigator, Beth Israel Deaconess Medical Center
  • Overall Contact(s)
    • Richard J Pollard, MD, 704-905-6637, rpollard@bidmc.harvard.edu

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