CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 enrolled
Drug / intervention
Ropivacaine with epinephrine injection +1 moredrug
Likely dose
Ropivacaine with epinephrine injection 1 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/NCT02112370
NCT02112370Phase 3Completed
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Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

Seoul National University Hospital·interventional·Posted Apr 11, 2014·Updated Aug 4, 2017

In Brief

A Phase 3 clinical trial evaluating Ropivacaine with epinephrine injection and Placebo for Thyroid Neoplasm and Goiter. Completed, enrolled 148 participants across 2 sites.

Detailed Summary

To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Neoplasm, Goiter
CountriesSouth Korea
CollaboratorsSeoul National University Bundang Hospital

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 11, 2014
Enrollment StartMay 1, 2014
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.2 years ago

Interventions

Ropivacaine with epinephrine injectiondrug

1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.

Placeboother

100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.