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Completed

NCT Number: NCT03762109

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dantrolene

Drug

muscle relaxant

Other names: Dantrium, Dantrolene Sodium

Placebo oral tablet

Drug

inactive pill

Other names: placebo

Primary outcomes

  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 outcomes

  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 24, 48 hours after surgery

    Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).

  4. 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

  5. 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.

  6. 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 20 (walking independently without a gait aid; best outcome).

  7. Oral Morphine Eqivalent (OME) Doses

    Time frame: During postoperative period

    OME in mg at 24 and 48 hours

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2018
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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