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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Thyroid Neoplasm; Goiter

Treatments: Drug: Ropivacaine with epinephrine injection; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02112370

B-1403/242-006

Details and patient eligibility

About

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

Full description

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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

148 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Ropivacaine with epinephrine injection

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine with epinephrine injection