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

Goiter Clinical Trial

— REBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02112370
• Other study ID #: B-1403/242-006
• Status: Recruiting
• Phase: Phase 3
• First received: April 7, 2014
• Last updated: February 23, 2015
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2015
• Source: Seoul National University Hospital
• Contact: Yong Joon Suh, MD
• Phone: 83-10-4534-6126
• Email: nicizm[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

Drug:
• Ropivacaine with epinephrine injection
According to the Ministry of Health and Welfare, ropivacaine is classified as no. 121- local analgesic and epinephrine as no. 245- adrenal hormone drug.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VAS pain scores for the first 12 hours	The visual analogue scale is utilized to assess the postoperative pain change for the first 12 hours.	For the first postoperative 12 hours	No
Secondary	Maximum of measured systolic blood pressures	The maximal systolic blood pressure is monitored during surgery.	During operation	Yes
Secondary	Maximum of measured diastolic blood pressures	The maximal diastolic blood pressure is monitored during surgery.	During operation	Yes
Secondary	Maximum of measured heart rates	The maximal heart rate is monitored during surgery.	During operation	Yes
Secondary	Blood loss amount	The blood loss amount is estimated at the end of surgery.	At the end of operation	Yes

External Links

•   Pharmacology of regional anaesthesia