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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHenrique Tedesco

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients who can have surgery under local anesthesia

Patients where more procedures are required in the same surgical session

Trial design

Design model

Single group

Treatments tested in this trial

  • Bupivacaine 0,5%

    Drug

    Injection of bupivacaine 0,5% in group A

  • Ropivacaine 0,75%

    Drug

    Injection of ropivacaine 0,75% in group B

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Group A - BupivacaineActive comparator 1 intervention
Group B: Group B - RopivacaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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)

Time frame
From surgery to 7 postoperative days

Secondary outcomes

Other outcomes

Sponsors and contacts

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Henrique Tedesco

Lead sponsor

Federal University of Rio Grande do Sul

Sponsor institution