NCT02112370

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 7, 2014

Results QC Date

June 7, 2016

Last Update Submit

April 25, 2017

Conditions

Thyroid NeoplasmGoiter

Keywords

RopivacaineEpinephrineEndoscopyRoboticsThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Maximum of Measured Systolic Blood Pressures

    participants were followed for the duration of the operation, an average of approximately 2.5 hours

  • Maximum of Measured Diastolic Blood Pressures

    participants were followed for the duration of the operation, an average of approximately 2.5 hours

  • Maximum of Measured Heart Rates

    participants were followed for the duration of the operation, an average of approximately 2.5 hours

  • Blood Loss Amount

    participants were followed for the duration of the operation, an average of approximately 2.5 hours

  • Operation Time

    participants were followed for the duration of the operation, an average of approximately 2.5 hours

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.

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.

Drug: Ropivacaine with epinephrine injection

Interventions

Ropivacaine with epinephrine injectionDRUG

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.

Also known as: Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A04900341
Ropivacaine with epinephrine injection
PlaceboOTHER

100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.

Also known as: CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

  • 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.

    PMID: 24576202BACKGROUND

  • 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.

    PMID: 22864036BACKGROUND

  • 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.

    PMID: 23397168BACKGROUND

  • 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.

    PMID: 21857470BACKGROUND

  • 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.

    PMID: 17308853BACKGROUND

  • 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.

    PMID: 22052422BACKGROUND

  • 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.

    PMID: 23558759BACKGROUND

  • 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.

    PMID: 23436099BACKGROUND

  • 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.

    PMID: 22136850BACKGROUND

  • 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.

    PMID: 19542833BACKGROUND

  • 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.

    PMID: 28562541DERIVED

Related Links

MeSH Terms

Conditions

Thyroid NeoplasmsGoiter

Interventions

RopivacaineEpinephrine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and Caveats

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

Results Point of Contact

Title
Dr. Kyu Eun Lee
Organization
Seoul National University Hospital Department of Surgery
kyueunlee@snu.ac.kr
+82)-2-2072-2817

Study Officials

  • Kyu Eun Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 11, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 4, 2017

Results First Posted

August 4, 2017

Record last verified: 2017-04

Locations

KR(2)