Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
Led by Henrique Tedesco · Updated on 2026-05-01
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65 weeks
Total Duration
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What this Trial Is About
Researchers are comparing the effects of two drugs, bupivacaine and ropivacaine, in third molar (wisdom tooth) removal surgery under general anesthesia. This early phase 1 clinical trial aims to find out if there is any difference between these drugs regarding vital signs, bleeding control during surgery, and levels of postoperative pain in healthy volunteers aged 18 to 60 years.
Participants will undergo a single third molar extraction surgery under general anesthesia. They will receive either bupivacaine 0.5% with epinephrine or ropivacaine 0.75% with epinephrine during the procedure. The study uses a split-mouth design, meaning each participant receives both drugs on different sides, allowing comparison of their effects in the same individual.
During the study, participants will be monitored for vital signs and bleeding control during surgery. They will also complete the Visual Analog Scale to report postoperative pain for up to seven days following surgery. The research team will evaluate differences in pain relief, hemostasis, and vital sign changes between the two drugs. The study will last from the surgery day through the first week after the procedure.
CONDITIONS
Brief Title
Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
Patients who can have surgery under local anesthesia
Patients where more procedures are required in the same surgical session
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants receive an injection of either bupivacaine 0.5% or ropivacaine 0.75% during third molar removal surgery under general anesthesia.
1 visit (in-person)
Post-operative Follow-up
Duration - 7 days after surgery
Participants are monitored for postoperative analgesic capacity, intraoperative hemostasis, and vital signs during anesthesia.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90040-060
Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial.