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

April 25, 2017 updated by: Kyu Eun Lee, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Other: Placebo
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Other Names:
  • CJ 0.9% Normal Saline injection 100cc
  • Insurance code: A11601752
Experimental: 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.
Drug: 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 for the experiment group.
Other Names:
  • Hanlim ropiva injection 7.5 mg/mL (20cc)
  • Insurance code: A37804211
  • Jeil epinephrine injection 1 mg/mL (1cc)
  • Insurance code: A04900341

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Pain Scores for the First 12 Hours
Time Frame: 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.
Postoperative 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum of Measured Systolic Blood Pressures
Time Frame: 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.
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Maximum of Measured Diastolic Blood Pressures
Time Frame: 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.
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Maximum of Measured Heart Rates
Time Frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
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
Time Frame: 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.
participants were followed for the duration of the operation, an average of approximately 2.5 hours
Operation Time
Time Frame: 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
participants were followed for the duration of the operation, an average of approximately 2.5 hours
NRS Change
Time Frame: 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)
0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Pain Killer Dose
Time Frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Change in pain killer usage with time
0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Kyu Eun Lee, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1403/242-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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