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

Phase 3

Completed

• Conditions: Thyroid Neoplasm; Goiter
• Interventions: Other: Placebo; Drug: Ropivacaine with epinephrine injection

• Registration Number: NCT02112370
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Results First Submitted: 2016-06-07
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-25
• Last Update Submitted: 2017-04-25
• Results First Posted: 2017-08-04
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Clinical diagnosis of thyroid neoplasm or benign goiter
• Scheduled for BABA endoscopic or robotic thyroidectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection	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.

Primary Outcome Measures

Name	Time	Method
NRS Pain Scores for the First 12 Hours	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 location in which flap dissection had taken place.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of