Neoplasms

Gland and Hormone Related Diseases

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Thyroid Neoplasms

Thyroid Diseases

Goiter

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Endocrine Gland Neoplasms

Head and Neck Neoplasms

Central Nervous System Depressants

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Vasoconstrictor Agents

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Ropivacaine

Epinephrine

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Epinephryl borate

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Sympathomimetics

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

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.

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.

Ropivacaine with epinephrine injection

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

Placebo

Kyu Eun Lee, MD, PhD

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.

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

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

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.

The maximal systolic blood pressure is monitored during surgery.

The maximal diastolic blood pressure is monitored during surgery.

The maximal heart rate is monitored during surgery.

The blood loss amount is estimated at the end of surgery.

The amount of time taken from start to the end of surgery

Change in NRS score a with time 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)

Seoul National University Bundang Hospital

Seoul National University Hospital

Associate Professor

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

Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.

Normal Saline Injection

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.

Ropivacaine with epinephrine injection: 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.

Ropivacaine With Epinephrine Injection

Total

Age, Continuous

Sex: Female, Male

Preoperative thyroid function test (T3, ng/dL)

Preoperative thyroid function test (free T4, ng/dL)

Preoperative thyroid function test (TSH, uIU/mL)

Robotic

Endoscopic

Method of operation (robotic/endoscopic)

Right

Left

Extent of operation (Right/Left/Total)

All patients referred for BABA robotic or endoscopic thyroidectomy at Seoul National University Bundang Hospital

1. Single-institution study
2. We did not directly examine the vasoconstrictive properties of epinephrine in helping reduce bleeding.
3. Issue regarding importance of statistical vs. clinical significance of the pain score remains to be addressed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy	NCT02112370	Thyroid Neoplas... Goiter	Ropivacaine wit... Placebo	18 Years - 70 Years	Seoul National University Hospital
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy	NCT02112370	Thyroid Neoplas... Goiter	Ropivacaine wit... Placebo	18 Years - 70 Years	Seoul National University Hospital

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