Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2009-07-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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%.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Bilateral superficial cervical block.
0.9% saline
20 ml of 0.9% saline
Ropivacaine 0.25%
Bilateral superficial cervical block
Ropivacaine
20 ml of Ropivacaine 0.25%.
Ropivacaine 0.5%
Bilateral superficial cervical block.
Ropivacaine
20 ml of Ropivacaine 0.5%.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.9% saline
20 ml of 0.9% saline
Ropivacaine
20 ml of Ropivacaine 0.25%.
Ropivacaine
20 ml of Ropivacaine 0.5%.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Agreed to participate in the study and sign the consent form
* ASA I-II
* Scheduled to undergo total thyroidectomy without neck dissection under general balanced anesthesia.
Exclusion Criteria
* Mental or cognitive deficit in existence, which makes it impossible to understand the patient visual analog scale of pain or the study protocol
* Body mass index greater than 45
* History of allergy to local anesthetics
* Intolerance or contraindication to any medication used in the study
* Skin infection at the site of the blockade
* Patients requiring neck dissection
* Pregnancy
* Preoperative use of opioid analgesics or non-opioids, corticosteroids or anti inflammatory non steroidal
* Patient's refusal to participate in the study
* Need for emergency reintervention within the first 24 hours postoperatively
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of Minas Gerais
OTHER
Lifecenter Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lifecenter Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos Leonardo A Boni, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lifecenter Hospital
Belo Horizonte, Minas Gerais, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Carlos leonardo A Boni, MD
Role: primary
Yerkes P Silva, PhD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE-0003.0.419.419-0
Identifier Type: -
Identifier Source: org_study_id