NCT02112370: REBT

Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

Completed Phase 3 Results posted Last updated 25 April 2017

What this trial tests

Phase 3 trial testing Ropivacaine with epinephrine injection in Thyroid Neoplasm in 148 participants. Completed in 1 June 2016.

Timeline

1 May 2014

Primary endpoint
1 May 2016

1 June 2016

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	148
Start date	1 May 2014
Primary completion	1 May 2016
Estimated completion	1 June 2016
Sites	2 locations across South Korea

Drugs / interventions tested

• Ropivacaine with epinephrine injection — full drug profile →
• Placebo

Conditions studied

• Thyroid Neoplasm — all drugs for Thyroid Neoplasm →
• Goiter — all drugs for Goiter →

Sponsor

Seoul National University Hospital

Who can join

Adults 18 to 70, any sex, with Thyroid Neoplasm or Goiter. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• NRS Pain Scores for the First 12 Hours
  Time frame: Postoperative 12 hours
  The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \~ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the "post-operative 48 hour" result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific locati

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).
   Lee JH, Suh YJ, Song RY, Yi JW, et al · · 2017 · cited 9× · PMID 28562541 · DOI 10.1097/md.0000000000006896