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

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

Detailed Description
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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.

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

Conditions
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Thyroid Neoplasm, Goiter

Intervention / Treatment
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* Drug: Ropivacaine with epinephrine injection
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. | Other: Placebo<br>* 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.<br>* Other names: Insurance code: A11601752;|
| Experimental: Ropivacaine with epinephrine injection<br>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. | Drug: Ropivacaine with epinephrine injection<br>* 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.<br>* Other names: Insurance code: A04900341;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum of Measured Systolic Blood Pressures | The maximal systolic blood pressure is monitored during surgery. | participants were followed for the duration of the operation, an average of approximately 2.5 hours | 
| Maximum of Measured Diastolic Blood Pressures | The maximal diastolic blood pressure is monitored during surgery. | participants were followed for the duration of the operation, an average of approximately 2.5 hours | 
| Maximum of Measured Heart Rates | The maximal heart rate is monitored during surgery. | participants were followed for the duration of the operation, an average of approximately 2.5 hours | 
| Blood Loss Amount | The blood loss amount is estimated at the end of surgery. | participants were followed for the duration of the operation, an average of approximately 2.5 hours | 
| Operation Time | The amount of time taken from start to the end of surgery | participants were followed for the duration of the operation, an average of approximately 2.5 hours | 
| NRS Change | 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) | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation | 
| Pain Killer Dose | Change in pain killer usage with time | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy