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The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Primary Purpose

Lumbar Spine Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dantrolene
Placebo Oral Tablet
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Injury focused on measuring Surgery, Dantrolene, Anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dantrolene Group

Placebo Oral Tablet Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).

Secondary Outcome Measures

Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
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.
Numerical Rating Scale (NRS) for Pain
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
ICU Length of Stay
The length of the patients stay in the ICU will be measured in hours
Hospital length of stay
The length of the patients stay in the hospital will be measured in days
Benzodiazepine use postoperatively
The number of patients who receive benzodiazepines after surgery will be recorded.
Morphine Equivalent Dose
The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)
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).

Full Information

First Posted
November 30, 2018
Last Updated
March 22, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03762109
Brief Title
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Official Title
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Injury
Keywords
Surgery, Dantrolene, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dantrolene Group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Oral Tablet Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dantrolene
Other Intervention Name(s)
Dantrium, Dantrolene Sodium
Intervention Description
muscle relaxant
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
placebo
Intervention Description
inactive pill
Primary Outcome Measure Information:
Title
Overall Benefit of Analgesia Score (OBAS)
Description
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time Frame
Measured at 24 hours after surgery
Secondary Outcome Measure Information:
Title
Overall Benefit of Analgesia Score (OBAS)
Description
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time Frame
Measured at 48 hours after surgery
Title
Richmond Agitation Sedation Scale (RASS)
Description
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.
Time Frame
Measured at 24 and 48 hours after surgery
Title
Numerical Rating Scale (NRS) for Pain
Description
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Time Frame
Measured at 0, 1, 2, 3, 24, 48 hours after surgery
Title
ICU Length of Stay
Description
The length of the patients stay in the ICU will be measured in hours
Time Frame
Until discharge from the hospital, on average 24 hours
Title
Hospital length of stay
Description
The length of the patients stay in the hospital will be measured in days
Time Frame
Until discharge from the hospital, on average three days
Title
Benzodiazepine use postoperatively
Description
The number of patients who receive benzodiazepines after surgery will be recorded.
Time Frame
Until discharge from the hospital, on average three days
Title
Morphine Equivalent Dose
Description
The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)
Time Frame
Duration of the patient's stay in the hospital, on average three days
Title
ICU Mobility Score
Description
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).
Time Frame
Measured at 24 and 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard J Pollard, MD
Phone
704-905-6637
Email
rpollard@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Evynne Gartner, BA
Email
egartner@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Pollard, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Pollard, MD
Phone
704-905-6637
First Name & Middle Initial & Last Name & Degree
Thy Nguyen, BS
Phone
617-632-8048

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

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