CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Bupivacaine Group +1 moredrug
Likely dose
Not stated in 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/NCT03482973
NCT03482973Phase 3Completed
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Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Beth Israel Deaconess Medical Center·interventional·Posted Mar 29, 2018·Updated Aug 3, 2020

In Brief

A Phase 3 clinical trial evaluating Bupivacaine Group and Placebo for Coronary Artery Disease and Sternal Pain. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Sternal Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 29, 2018
Enrollment StartJun 21, 2018
Primary CompletionNov 25, 2019
Study CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.3 years ago

Interventions

Bupivacaine Groupdrug

20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

Placeboother

20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).