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

Primary Purpose

Thyroid Neoplasm, Goiter

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ropivacaine with epinephrine injection
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasm focused on measuring Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ropivacaine with epinephrine injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum of Measured Systolic Blood Pressures
The maximal systolic blood pressure is monitored during surgery.
Maximum of Measured Diastolic Blood Pressures
The maximal diastolic blood pressure is monitored during surgery.
Maximum of Measured Heart Rates
The maximal heart rate is monitored during surgery.
Blood Loss Amount
The blood loss amount is estimated at the end of surgery.
Operation Time
The amount of time taken from start to the end of surgery
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)
Pain Killer Dose
Change in pain killer usage with time

Full Information

First Posted
April 7, 2014
Last Updated
April 25, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02112370
Brief Title
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Acronym
REBT
Official Title
Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm, Goiter
Keywords
Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Arm Title
Ropivacaine with epinephrine injection
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine with epinephrine injection
Other Intervention Name(s)
Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A04900341
Intervention 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 for the experiment group.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752
Intervention Description
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Primary Outcome Measure Information:
Title
NRS Pain Scores for the First 12 Hours
Description
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
Secondary Outcome Measure Information:
Title
Maximum of Measured Systolic Blood Pressures
Description
The maximal systolic blood pressure is monitored during surgery.
Time Frame
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Title
Maximum of Measured Diastolic Blood Pressures
Description
The maximal diastolic blood pressure is monitored during surgery.
Time Frame
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Title
Maximum of Measured Heart Rates
Description
The maximal heart rate is monitored during surgery.
Time Frame
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Title
Blood Loss Amount
Description
The blood loss amount is estimated at the end of surgery.
Time Frame
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Title
Operation Time
Description
The amount of time taken from start to the end of surgery
Time Frame
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Title
NRS Change
Description
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)
Time Frame
0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Title
Pain Killer Dose
Description
Change in pain killer usage with time
Time Frame
0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Eun Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24576202
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Results Reference
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Citation
Lee JH, Suh YJ, Song RY, Yi JW, Yu HW, Kwon H, Choi JY, Lee KE. Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial). Medicine (Baltimore). 2017 Jun;96(22):e6896. doi: 10.1097/MD.0000000000006896.
Results Reference
derived
Links:
URL
http://www.frca.co.uk/article.aspx?articleid=100816
Description
Pharmacology of regional anaesthesia

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

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