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

NCT07108465 | Recruiting Early Phase 1

• 1 other identifier: 89726325.2.0000.5327
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Third Molars Extraction

Outcome Measures

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)

  From surgery to 7 postoperative days

Study Arms (2)

Group A - Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0,5%

Group B - Ropivacaine

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0,75%

Interventions

Bupivacaine 0,5% DRUG

Injection of bupivacaine 0,5% in group A

Group A - Bupivacaine

Ropivacaine 0,75% DRUG

Injection of ropivacaine 0,75% in group B

Group B - Ropivacaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• Patients who can have surgery under local anesthesia
• Patients where more procedures are required in the same surgical session

Sponsors & Collaborators

• Henrique Tedesco: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

RECRUITING

Related Publications (1)

• Kalath RN, Kulal R, Gopinath S. Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial. J Dent Anesth Pain Med. 2021 Aug;21(4):337-344. doi: 10.17245/jdapm.2021.21.4.337. Epub 2021 Jul 30.

  PMID: 34395901 BACKGROUND

Central Study Contacts

Henrique T Oliveira

CONTACT

55 51999601939; htedesco99@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 7, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)