The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Lumbar Spine Injury Clinical Trial

Official title:

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762109
• Other study ID #: 2018P000799
• Status: Recruiting
• Phase: Phase 2
• Start date: July 29, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Richard J Pollard, MD
• Phone: 704-905-6637
• Email: rpollard[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spine Injury
• Spinal Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Benzodiazepine use postoperatively	The number of patients who receive benzodiazepines after surgery will be recorded.	Until discharge from the hospital, on average three days
Secondary	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
Secondary	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