NCT03936387

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

Completed Phase 3 Results posted Last updated 5 April 2021

What this trial tests

Phase 3 trial testing Ropivacaine in Pain, Postoperative in 10 participants. Completed in 12 September 2019.

Timeline

1 July 2019

Primary endpoint
1 September 2019

12 September 2019

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 July 2019
Primary completion	1 September 2019
Estimated completion	12 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Ropivacaine (ROPIVACAINE) — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Boston Children's Hospital

Who can join

Adults 3 to 21, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Completed a Successful Intervention With No Major Adverse Events Primary · 48 hours

For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes.

Group	Value	95% CI
Bilateral Erector Spinae Blocks	10

Number of Participants Who Completed a Successful Intervention With a Full Data Set Secondary · 48 hours

Secondary measures of feasibility will include aggregate 'data integrity' as defined by successful collection of 75% or greater of all possible data points for successfully completed subjects as well as 'efficient intervention duration' as evaluated by intervention completion time being less than 40 minutes.

Group	Value	95% CI
Bilateral Erector Spinae Blocks	10

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.