Clinical trial NCT02112370: Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Official title: Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Neoplasm
Goiter
Keywords: Ropivacaine
Epinephrine
Endoscopy
Robotics
Thyroidectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2014-04-11
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NRS Pain Scores for the First 12 Hours
timeFrame: Postoperative 12 hours
Secondary outcomes:
measure: Maximum of Measured Systolic Blood Pressures
timeFrame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
measure: Maximum of Measured Diastolic Blood Pressures
timeFrame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
measure: Maximum of Measured Heart Rates
timeFrame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
measure: Blood Loss Amount
timeFrame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
measure: Operation Time
timeFrame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
measure: NRS Change
timeFrame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
measure: Pain Killer Dose
timeFrame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyu Eun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.