Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine 0,5%, Ropivacaine 0,75%.
- Who it may be relevant to
- Registry conditions: Third Molars Extraction. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to compare the efficacy of bupivacaine and ropivacaine in third molar removal surgery under general anesthesia in healthy volunteers. The main question aims to determine whether there is any difference in vital signs, hemostasis and postoperative pain between ropivacaine and bupivacaine in patients undergoing third molars extraction under general anesthesia. Researchers will compare bupivacaine and ropivacaine in a split-mouth study to determine if one drug is more effective in third molar extraction surgery under general anesthesia (better hemostasis, less postoperative pain, and fewer changes in vital signs). Participants will undergo a single surgical procedure and complete the Visual Analog Scale to record postoperative pain
Interventions
- Drug Bupivacaine 0,5%
Injection of bupivacaine 0,5% in group A - Drug Ropivacaine 0,75%
Injection of ropivacaine 0,75% in group B
Primary outcome measures
- Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia. [Time frame: From surgery to 7 postoperative days]
Eligibility criteria
Inclusion criteria
- Patients aged 18 to 60
- Patients ASA Physical Status Classification I and II
- Patients with impacted or semi-impacted lower third molars with similar positioning on both sides according to the Pell and Gregory classification
Exclusion criteria
- Patients who can have surgery under local anesthesia
- Patients where more procedures are required in the same surgical session
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Publications
- Kalath RN, Kulal R, Gopinath S. Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial. J Dent Anesth Pain Med. 2021 Aug;21(4):337-344. doi: 10.17245/jdapm.2021.21.4.337. Epub 2021 Jul 30. PMID 34395901
Identifiers
NCT: NCT07108465 · 89726325.2.0000.5327