The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Phase 2

Completed

• Conditions: Lumbar Spine Injury
• Interventions: Drug: Placebo Oral Tablet; Drug: Dantrolene

• Registration Number: NCT03762109
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-07-29
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet Group	Placebo Oral Tablet	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.
Dantrolene Group	Dantrolene	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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
Benzodiazepine use postoperatively	Until discharge from the hospital, on average three days	The number of patients who receive benzodiazepines after surgery will be recorded.
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
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)
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).
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).
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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States