Thyroid NeoplasmPhase 3REBTNCT02112370

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

A Phase 3 study testing Ropivacaine with epinephrine injection in people with Thyroid Neoplasm and Goiter, run by Seoul National University Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Thyroid Neoplasm, Goiter
What is being tested?: Ropivacaine with epinephrine injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 2 sitesSouth Korea
Study dates: May 2014to Jun 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Completion thyroidectomy
Modified radical neck dissection
Allergy history
Stroke history
Uncontrolled hypertension
Uncontrolled diabetes

Show all 11Show fewer

Coagulopathy
Severe cardiovascular disease
Severe pulmonary disease
Chronic kidney disease
Pregnant

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions: Thyroid Neoplasm, Goiter
Being tested: Ropivacaine with epinephrine injection, Placebo
Keywords: Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy
Medical subject headings: Thyroid Neoplasms, Goiter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropivacaine with epinephrine injectionDrug
Also called Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A04900341
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.
PlaceboOther
Also called CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.

Study groups in NCT02112370
Study group	Role	What they receive
Placebo	Placebo comparator	100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. Receives: Other: Placebo
Ropivacaine with epinephrine injection	Experimental	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. Receives: Drug: Ropivacaine with epinephrine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative 12 hours

Secondary outcomes (7)

Maximum of Measured Systolic Blood Pressures
The maximal systolic blood pressure is monitored during surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Pain Killer Dose
Change in pain killer usage with time
Measured: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2016

First posted11 Apr 2014 (estimated)
Study startMay 2014
Primary completionMay 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Thyroid NeoplasmStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02112370
Sponsor's protocol ID: B-1403/242-006
Acronym: REBT
Status last verified: Apr 2017
First submitted: 7 Apr 2014
Last updated: 4 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Hristovska AM, Kristensen BB, Rasmussen MA, Rasmussen YH, Elving LB, Nielsen CV, Kehlet H. Effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy: a randomized, placebo-controlled trial. Acta Obstet Gynecol Scand. 2014 Mar;93(3):233-8. doi: 10.1111/aogs.12319.
PubMed 24576202
Miratashi SA, Behdad S, Ayatollahi V, Ahmadi A. Hemodynamic effects of intraocular epinephrine during cataract surgery: a double blinded placebo controlled randomized clinical trial. Nepal J Ophthalmol. 2012 Jul-Dec;4(2):288-94. doi: 10.3126/nepjoph.v4i2.6546.
PubMed 22864036
Kim SJ, Lee KE, Myong JP, Koo do H, Lee J, Youn YK. Prospective study of sensation in anterior chest areas before and after a bilateral axillo-breast approach for endoscopic/robotic thyroid surgery. World J Surg. 2013 May;37(5):1147-53. doi: 10.1007/s00268-013-1934-8.
PubMed 23397168
Lee KE, Choi JY, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy. Surg Laparosc Endosc Percutan Tech. 2011 Aug;21(4):230-6. doi: 10.1097/SLE.0b013e31822d0455.
PubMed 21857470
Choe JH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy using a new bilateral axillo-breast approach. World J Surg. 2007 Mar;31(3):601-6. doi: 10.1007/s00268-006-0481-y.
PubMed 17308853
Choi JY, Lee KE, Chung KW, Kim SW, Choe JH, Koo do H, Kim SJ, Lee J, Chung YS, Oh SK, Youn YK. Endoscopic thyroidectomy via bilateral axillo-breast approach (BABA): review of 512 cases in a single institute. Surg Endosc. 2012 Apr;26(4):948-55. doi: 10.1007/s00464-011-1973-x. Epub 2011 Nov 4.
PubMed 22052422
Kwon H, Koo do H, Choi JY, Kim E, Lee KE, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy for Graves' disease: an initial experience in a single institute. World J Surg. 2013 Jul;37(7):1576-81. doi: 10.1007/s00268-013-2027-4.
PubMed 23558759
Lee KE, Kim E, Koo do H, Choi JY, Kim KH, Youn YK. Robotic thyroidectomy by bilateral axillo-breast approach: review of 1,026 cases and surgical completeness. Surg Endosc. 2013 Aug;27(8):2955-62. doi: 10.1007/s00464-013-2863-1. Epub 2013 Feb 23.
PubMed 23436099
Lee KE, Koo do H, Im HJ, Park SK, Choi JY, Paeng JC, Chung JK, Oh SK, Youn YK. Surgical completeness of bilateral axillo-breast approach robotic thyroidectomy: comparison with conventional open thyroidectomy after propensity score matching. Surgery. 2011 Dec;150(6):1266-74. doi: 10.1016/j.surg.2011.09.015.
PubMed 22136850
Lee KE, Rao J, Youn YK. Endoscopic thyroidectomy with the da Vinci robot system using the bilateral axillary breast approach (BABA) technique: our initial experience. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):e71-5. doi: 10.1097/SLE.0b013e3181a4ccae.
PubMed 19542833
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.
PubMed 28562541

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thyroid Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
ClinicalTrials.gov ID: NCT02112370
Acronym / sponsor ID: REBT / B-1403/242-006
Conditions: Thyroid Neoplasm, Goiter
Keywords: Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Seoul National University Bundang Hospital
Study start: May 2014
Primary completion: May 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 11 Apr 2014 (estimated)
Results: Posted 4 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection	Experimental	Drug: Ropivacaine with epinephrine injection1 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (11 listed)

Completion thyroidectomy
Modified radical neck dissection
Allergy history
Stroke history
Uncontrolled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ropivacaine with epinephrine injectionAlso: Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A049003411 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.	Drug	Ropivacaine with epinephrine injection
PlaceboAlso: CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.	Other	Placebo

Primary outcome

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.

7 secondary outcomes

Maximum of Measured Systolic Blood Pressures
Time frame: 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
Maximum of Measured Heart Rates
Time frame: 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
Operation Time
Time frame: 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
Pain Killer Dose
Time frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

Results and safety

Results posted to the registry on 4 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Saline Injection	74	74
Ropivacaine With Epinephrine Injection	74	74

Primary outcome: NRS Pain Scores for the First 12 Hours

Time frame: Postoperative 12 hours. Mean (Standard Deviation). Unit: points

Measure	Normal Saline Injection n = 74	Ropivacaine With Epinephrine Injection n = 74
Swallowing difficulty	4.93 (1.79)	4.12 (1.87)
Anterior neck pain	4.50 (2.10)	3.69 (1.94)
Right chest pain	3.99 (2.27)	3.16 (1.96)
Left chest pain	3.74 (1.94)	4.51 (2.45)
Back pain	0.65 (1.50)	0.28 (1.05)
Posterior neck pain	1.47 (2.07)	1.65 (2.40)

Normal Saline Injection vs Ropivacaine With Epinephrine Injection: p = 0.008, t-test, 2 sided
Normal Saline Injection vs Ropivacaine With Epinephrine Injection: p = 0.016, t-test, 2 sided
Normal Saline Injection vs Ropivacaine With Epinephrine Injection: p = 0.019, t-test, 2 sided

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Saline Injection	0 of 74 (0%)	0 of 74 (0%)	Not reported
Ropivacaine With Epinephrine Injection	0 of 74 (0%)	0 of 74 (0%)	Not reported

Limitations and caveats (from the sponsor): 1. Single-institution study 2. We did not directly examine the vasoconstrictive properties of epinephrine in helping reduce bleeding. 3. Issue regarding importance of statistical vs. clinical significance of the pain score remains to be addressed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24576202Hristovska AM, Kristensen BB, Rasmussen MA, Rasmussen YH, Elving LB, Nielsen CV, Kehlet H. Effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy: a randomized, placebo-controlled trial. Acta Obstet Gynecol Scand. 2014 Mar;93(3):233-8. doi: 10.1111/aogs.12319.
Background: PubMed 22864036Miratashi SA, Behdad S, Ayatollahi V, Ahmadi A. Hemodynamic effects of intraocular epinephrine during cataract surgery: a double blinded placebo controlled randomized clinical trial. Nepal J Ophthalmol. 2012 Jul-Dec;4(2):288-94. doi: 10.3126/nepjoph.v4i2.6546.
Background: PubMed 23397168Kim SJ, Lee KE, Myong JP, Koo do H, Lee J, Youn YK. Prospective study of sensation in anterior chest areas before and after a bilateral axillo-breast approach for endoscopic/robotic thyroid surgery. World J Surg. 2013 May;37(5):1147-53. doi: 10.1007/s00268-013-1934-8.
Background: PubMed 21857470Lee KE, Choi JY, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy. Surg Laparosc Endosc Percutan Tech. 2011 Aug;21(4):230-6. doi: 10.1097/SLE.0b013e31822d0455.
Background: PubMed 17308853Choe JH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy using a new bilateral axillo-breast approach. World J Surg. 2007 Mar;31(3):601-6. doi: 10.1007/s00268-006-0481-y.
Background: PubMed 22052422Choi JY, Lee KE, Chung KW, Kim SW, Choe JH, Koo do H, Kim SJ, Lee J, Chung YS, Oh SK, Youn YK. Endoscopic thyroidectomy via bilateral axillo-breast approach (BABA): review of 512 cases in a single institute. Surg Endosc. 2012 Apr;26(4):948-55. doi: 10.1007/s00464-011-1973-x. Epub 2011 Nov 4.
Background: PubMed 23558759Kwon H, Koo do H, Choi JY, Kim E, Lee KE, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy for Graves' disease: an initial experience in a single institute. World J Surg. 2013 Jul;37(7):1576-81. doi: 10.1007/s00268-013-2027-4.
Background: PubMed 23436099Lee KE, Kim E, Koo do H, Choi JY, Kim KH, Youn YK. Robotic thyroidectomy by bilateral axillo-breast approach: review of 1,026 cases and surgical completeness. Surg Endosc. 2013 Aug;27(8):2955-62. doi: 10.1007/s00464-013-2863-1. Epub 2013 Feb 23.
Background: PubMed 22136850Lee KE, Koo do H, Im HJ, Park SK, Choi JY, Paeng JC, Chung JK, Oh SK, Youn YK. Surgical completeness of bilateral axillo-breast approach robotic thyroidectomy: comparison with conventional open thyroidectomy after propensity score matching. Surgery. 2011 Dec;150(6):1266-74. doi: 10.1016/j.surg.2011.09.015.
Background: PubMed 19542833Lee KE, Rao J, Youn YK. Endoscopic thyroidectomy with the da Vinci robot system using the bilateral axillary breast approach (BABA) technique: our initial experience. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):e71-5. doi: 10.1097/SLE.0b013e3181a4ccae.
Derived from this study: PubMed 28562541Lee 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.
Pharmacology of regional anaesthesiaLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyu Eun Lee, MD, PhD principal investigator

Seoul National University Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine with epinephrine injection in people with Thyroid Neoplasm and Goiter, run by Seoul National University Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NRS Pain Scores for the First 12 Hours (time frame: Postoperative 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112370, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.