The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03762109
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spine Injury	Drug: Dantrolene; Drug: Placebo Oral Tablet	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
• Actual Study Start Date: Jul 29, 2019
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall Benefit of Analgesia Score (OBAS) [Measured at 24 hours after surgery]

   OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).

Secondary Outcome Measures

1. Overall Benefit of Analgesia Score (OBAS) [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) [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 [Measured at 0, 1, 2, 3, 24, 48 hours after surgery]

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

4. ICU Length of Stay [Until discharge from the hospital, on average 24 hours]

   The length of the patients stay in the ICU will be measured in hours

5. Hospital length of stay [Until discharge from the hospital, on average three days]

   The length of the patients stay in the hospital will be measured in days

6. Benzodiazepine use postoperatively [Until discharge from the hospital, on average three days]

   The number of patients who receive benzodiazepines after surgery will be recorded.

7. Morphine Equivalent Dose [Duration of the patient's stay in the hospital, on average three days]

   The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)

8. ICU Mobility Score [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 10 (walking independently without a gait aid; best outcome).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard J. Pollard, Director, Neurosurgical Anesthesia Fellowship, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03762109
• Other Study ID Numbers: 2018P000799
• First Posted: Dec 3, 2018
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Richard J. Pollard, Director, Neurosurgical Anesthesia Fellowship, Beth Israel Deaconess Medical Center: Surgery; Dantrolene; Anesthesia
• Additional relevant MeSH terms: Spinal Injuries; Dantrolene

Study Results

No Results Posted as of Mar 3, 2022