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| Name | Class |
|---|---|
| Federal University of Minas Gerais | OTHER |
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The objective of this study is to compare the postoperative analgesia afforded by bilateral superficial cervical block using different concentrations of local anesthetic (ropivacaine) in patients undergoing total thyroidectomy for the mini-incision technique, performed by the same surgical team.
In this study we will evaluate the efficacy of bilateral superficial cervical block associated with balanced general anesthesia with remifentanil as opioid of choice in preventing postoperative pain in patients who underwent total thyroidectomy with mini incision without neck dissection.A hundred and twenty patients ASA I - II will be assessed and allocated randomly (through a table of random numbers) into three groups for analgesia for post-operative:
Group 1: bilateral superficial cervical block with 20 ml of 0.9% saline (placebo); Group 2: bilateral superficial cervical block with 20 ml ropivacaine 0.25%; Group 3: bilateral superficial cervical block with 20 ml ropivacaine 0.5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Bilateral superficial cervical block. |
|
| Ropivacaine 0.25% | Experimental | Bilateral superficial cervical block |
|
| Ropivacaine 0.5% | Experimental | Bilateral superficial cervical block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% saline | Drug | 20 ml of 0.9% saline |
| |
| Ropivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain assessment according to Visual Analogue Scale | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of morphine | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Leonardo A Boni, MD | Contact | 00553191851959 | leonardoboni@gmail.com | |
| Yerkes P Silva, PhD | Contact | 00553199933384 | yerkesps@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Leonardo A Boni, MD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifecenter Hospital | Recruiting | Belo Horizonte | Minas Gerais | 30110090 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17681971 | Background | Andrieu G, Amrouni H, Robin E, Carnaille B, Wattier JM, Pattou F, Vallet B, Lebuffe G. Analgesic efficacy of bilateral superficial cervical plexus block administered before thyroid surgery under general anaesthesia. Br J Anaesth. 2007 Oct;99(4):561-6. doi: 10.1093/bja/aem230. Epub 2007 Aug 6. | |
| 16418022 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 9, 2012 | |
| Reset | Feb 8, 2012 | |
| Release | Feb 15, 2013 | |
| Reset | Mar 20, 2013 | |
| Release | Jul 28, 2014 | |
| Reset | Aug 14, 2014 | |
| Release | Aug 31, 2015 | |
| Reset | Sep 30, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2012 | Feb 8, 2012 | |||
| Feb 15, 2013 |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
20 ml of Ropivacaine 0.25%. |
|
| Ropivacaine | Drug | 20 ml of Ropivacaine 0.5%. |
|
| Herbland A, Cantini O, Reynier P, Valat P, Jougon J, Arimone Y, Janvier G. The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):34-9. doi: 10.1016/j.rapm.2005.10.008. |
| 16551919 | Background | Eti Z, Irmak P, Gulluoglu BM, Manukyan MN, Gogus FY. Does bilateral superficial cervical plexus block decrease analgesic requirement after thyroid surgery? Anesth Analg. 2006 Apr;102(4):1174-6. doi: 10.1213/01.ane.0000202383.51830.c4. |
| 20632263 | Background | Steffen T, Warschkow R, Brandle M, Tarantino I, Clerici T. Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery. Br J Surg. 2010 Jul;97(7):1000-6. doi: 10.1002/bjs.7077. |
| Mar 20, 2013 |
| Jul 28, 2014 | Aug 14, 2014 |
| Aug 31, 2015 | Sep 30, 2015 |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |