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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine with epinephrine injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum of Measured Systolic Blood Pressures | The maximal systolic blood pressure is monitored during surgery. | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
| Maximum of Measured Diastolic Blood Pressures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Eun Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24576202 | Background | 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. | |
| 22864036 | Background |
| Label | URL |
|---|---|
| Pharmacology of regional anaesthesia | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline Injection | 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. |
| FG001 | Ropivacaine With Epinephrine Injection | 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. Ropivacaine with epinephrine injection: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients referred for BABA robotic or endoscopic thyroidectomy at Seoul National University Bundang Hospital
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline Injection | 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. |
| BG001 | Ropivacaine With Epinephrine Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | points | Postoperative 12 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline Injection | 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyu Eun Lee | Seoul National University Hospital Department of Surgery | +82)-2-2072-2817 | kyueunlee@snu.ac.kr |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D006042 | Goiter |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Placebo | Other | 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group. |
|
|
The maximal diastolic blood pressure is monitored during surgery. |
| 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. | 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. | 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 | 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) | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation |
| Pain Killer Dose | Change in pain killer usage with time | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation |
| Seoul |
| 110-744 |
| South Korea |
| 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. |
| 23397168 | Background | 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. |
| 21857470 | Background | 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. |
| 17308853 | Background | 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. |
| 22052422 | Background | 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. |
| 23558759 | Background | 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. |
| 23436099 | Background | 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. |
| 22136850 | Background | 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. |
| 19542833 | Background | 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. |
| 28562541 | Derived | 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. |
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. Ropivacaine with epinephrine injection: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Preoperative thyroid function test (T3, ng/dL) | Mean | Standard Deviation | ng/dL |
|
| Preoperative thyroid function test (free T4, ng/dL) | Mean | Standard Deviation | ng/dL |
|
| Preoperative thyroid function test (TSH, uIU/mL) | Mean | Standard Deviation | uIU/mL |
|
| Method of operation (robotic/endoscopic) | Number | participants |
|
| Extent of operation (Right/Left/Total) | Number | participants |
|
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. Ropivacaine with epinephrine injection: 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. |
|
|
|
| Secondary | Maximum of Measured Systolic Blood Pressures | The maximal systolic blood pressure is monitored during surgery. | Posted | Mean | Standard Deviation | mmHg | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
|
|
|
| Secondary | Maximum of Measured Diastolic Blood Pressures | The maximal diastolic blood pressure is monitored during surgery. | Posted | Mean | Standard Deviation | mmHg | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
|
|
|
| Secondary | Maximum of Measured Heart Rates | The maximal heart rate is monitored during surgery. | Posted | Mean | Standard Deviation | beats per minute | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
|
|
|
| Secondary | Blood Loss Amount | The blood loss amount is estimated at the end of surgery. | Posted | Mean | Standard Deviation | ml | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
|
|
|
| Secondary | Operation Time | The amount of time taken from start to the end of surgery | Posted | Mean | Standard Deviation | minutes | participants were followed for the duration of the operation, an average of approximately 2.5 hours |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | scores on a scale | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation |
|
|
|
| Secondary | Pain Killer Dose | Change in pain killer usage with time | Posted | Mean | Standard Deviation | vials (15mg ketorolac per vial) | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Ropivacaine With Epinephrine Injection | 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. Ropivacaine with epinephrine injection: 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. | 0 | 74 | 0 | 74 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 2 hour |
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| 4 hour |
|
| 6 hour |
|
| 9 hour |
|
| 12 hour |
|
| 24 hour |
|
| 48 hour |
|
| 2 hour |
|
| 4 hour |
|
| 6 hour |
|
| 9 hour |
|
| 12 hour |
|
| 24 hour |
|
| 48 hour |
|