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

Henrique Tedesco

Status and phase: Enrolling; Early Phase 1

Conditions: Third Molars Extraction

Treatments: Drug: Bupivacaine 0,5%; Drug: Ropivacaine 0,75%

Study type: Interventional

Funder types: Other

Identifiers

NCT07108465

89726325.2.0000.5327

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Group A - Bupivacaine

Active Comparator group

Description:

use of bupivacaine 0,5% + epinephrine 0,2mL in third molar surgery in general anesthesia

Treatment:

Drug: Bupivacaine 0,5%

Group B - Ropivacaine

Active Comparator group

Description:

use of ropivacaine 0,75% + epinephrine 0,2mL in third molar surgery in general anesthesia

Treatment:

Drug: Ropivacaine 0,75%