The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Sponsors

Lead Sponsor: Beth Israel Deaconess Medical Center

Source Beth Israel Deaconess Medical Center
Brief 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.

Overall Status Recruiting
Start Date 2019-07-29
Completion Date 2021-06-30
Primary Completion Date 2021-06-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall Benefit of Analgesia Score (OBAS) Measured at 24 hours after surgery
Secondary Outcome
Measure Time Frame
Overall Benefit of Analgesia Score (OBAS) Measured at 48 hours after surgery
Richmond Agitation Sedation Scale (RASS) Measured at 24 and 48 hours after surgery
Numerical Rating Scale (NRS) for Pain Measured at 0, 1, 2, 3, 24, 48 hours after surgery
ICU Length of Stay Until discharge from the hospital, on average 24 hours
Hospital length of stay Until discharge from the hospital, on average three days
Benzodiazepine use postoperatively Until discharge from the hospital, on average three days
Morphine Equivalent Dose Duration of the patient's stay in the hospital, on average three days
ICU Mobility Score Measured at 24 and 48 hours after surgery
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dantrolene

Description: muscle relaxant

Arm Group Label: Dantrolene Group

Intervention Type: Drug

Intervention Name: Placebo Oral Tablet

Description: inactive pill

Arm Group Label: Placebo Oral Tablet Group

Other Name: placebo

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Richard J Pollard, MD Principal Investigator Beth Israel Deaconess Medical Center
Overall Contact

Last Name: Richard J Pollard, MD

Phone: 704-905-6637

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Beth Israel Deaconess Medical Center Richard Pollard, MD 704-905-6637
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Beth Israel Deaconess Medical Center

Investigator Full Name: Richard J. Pollard

Investigator Title: Director, Neurosurgical Anesthesia Fellowship

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dantrolene Group

Type: Experimental

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.

Label: Placebo Oral Tablet Group

Type: Placebo Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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