Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia

Not Applicable

Recruiting

• Conditions: Third Molars Extraction
• Interventions: Drug: Bupivacaine 0,5%; Drug: Ropivacaine 0,75%

• Registration Number: NCT07108465
• Lead Sponsor: Henrique Tedesco

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-01
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A - Bupivacaine	Bupivacaine 0,5%	use of bupivacaine 0,5% + epinephrine 0,2mL in third molar surgery in general anesthesia
Group B - Ropivacaine	Ropivacaine 0,75%	use of ropivacaine 0,75% + epinephrine 0,2mL in third molar surgery in general anesthesia

Primary Outcome Measures

Name	Time	Method
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.	From surgery to 7 postoperative days	The Visual Analog Scale (0-10 VAS) can be interpreted as no pain (0), mild (1-3), moderate (4-6),severe (7-9),or worse pain (10)

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil