Actively Recruiting

Early Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID07108465

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

15

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

H

Henrique T Oliveira

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial.

Remya Nath Kalath, Rithesh Kulal, Sharika Gopinath

https://pubmed.ncbi.nlm.nih.gov/34395901