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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spine Injury
• Intervention / Treatment: Drug: Dantrolene; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Richard J Pollard, MD; Phone Number: 704-905-6637; Email: rpollard@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Richard Pollard, MD; Phone Number: 704-905-6637
      • Contact: Thy Nguyen, BS; Phone Number: 617-632-8048

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Richard J Pollard, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Anesthesia; Dantrolene
• Additional Relevant MeSH Terms: Wounds and Injuries; Back Injuries; Spinal Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Dantrolene
• Other Study ID Numbers: 2018P000799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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