The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Lumbar Spine Injury

Treatments: Drug: Dantrolene; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03762109

2018P000799

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Dantrolene Group

Experimental group

Description:

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.

Treatment:

Drug: Dantrolene

Placebo Oral Tablet Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet