CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled / 116 target
Drug / intervention
Dantrolene +1 moredrug
Likely dose
25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03762109
NCT03762109Phase 2CompletedOn Track (1.4/mo)Completion was 25mo ago
CompareCT.gov

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Beth Israel Deaconess Medical Center·interventional·Posted Dec 3, 2018·Updated Jun 18, 2026

In Brief

A Phase 2 clinical trial evaluating Dantrolene and Placebo Oral Tablet for Lumbar Spine Injury. Completed, enrolled 116 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spine Injury
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 3, 2018
Enrollment StartJul 29, 2019
Primary CompletionJun 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.6 years ago

Arms & Interventions

Dantrolene Groupexperimental

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
Placebo Oral Tablet Groupplacebo_comparator

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

Interventions

Dantrolenedrug

muscle relaxant

Placebo Oral Tabletdrug

inactive pill