Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

Seoul National University Hospital148 enrolled

Overview

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

Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

148

Conditions

Thyroid Neoplasm Goiter

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of thyroid neoplasm or benign goiter * Scheduled for BABA endoscopic or robotic thyroidectomy Exclusion Criteria: * Completion thyroidectomy * Modified radical neck dissection * Allergy history * Stroke history * Uncontrolled hypertension * Uncontrolled diabetes * Coagulopathy * Severe cardiovascular disease * Severe pulmonary disease * Chronic kidney disease * Pregnant

Locations (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

NRS Pain Scores for the First 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 location in which flap dissection had taken place.

Time frame: Postoperative 12 hours