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

Condition(s) targeted: Thyroid Neoplasm; Goiter

Intervention: Ropivacaine with epinephrine injection (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Kyu Eun Lee, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Yong Joon Suh, MD, Phone: 83-10-4534-6126, Email: nicizm@gmail.com

To assess the pain relief and the hemodynamic stability 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change of VAS pain scores for the first 12 hours

Secondary outcome:

Maximum of measured systolic blood pressures

Maximum of measured diastolic blood pressures

Maximum of measured heart rates

Blood loss amount

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Yong Joon Suh, MD, Phone: 83-10-4534-6126, Email: nicizm@gmail.com

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Not yet recruiting
Yong Joon Suh, MD, Phone: 82-10-4534-6126, Email: nicizm@gmail.com
Kyueun Lee, Ph.D, Principal Investigator
Su-jin Kim, MD, Sub-Investigator
Hyungju Kwon, MD, Sub-Investigator

Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, Korea, Republic of; Recruiting
Yong Joon Suh, MD, Phone: 82-10-4534-1626, Email: nicizm@gmail.com
June Young Choi, MD, Principal Investigator
Kyu Hyung Kim, MD, Sub-Investigator
Jun Woo Jung, MD, Sub-Investigator
Yong Joon Suh, MD, Sub-Investigator
Joon Hyop Lee, MD, Sub-Investigator

Pharmacology of regional anaesthesia

Related 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.

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: http://dx.doi.org/10.3126/nepjoph.v4i2.6546.

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.

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.

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.

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.

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.

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.

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.

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.

Starting date: May 2014
Last updated: February 23, 2015