CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Ropivacainedrug
Likely dose
Ropivacaine 2mlfrom 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/NCT03936387
NCT03936387Phase 3Completed

Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study

Boston Children's Hospital·interventional·Posted May 3, 2019·Updated Apr 5, 2021

In Brief

A Phase 3 clinical trial evaluating Ropivacaine for Pain, Postoperative. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same. Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 3, 2019
Enrollment StartJul 1, 2019
Primary CompletionSep 1, 2019
Study CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.2 years ago

Interventions

Ropivacainedrug

Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.