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

NCT ID: NCT07108465

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Third Molars Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A - Bupivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0,5%

Intervention Type DRUG

Injection of bupivacaine 0,5% in group A

Group B - Ropivacaine

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0,75%

Intervention Type DRUG

Injection of ropivacaine 0,75% in group B

Interventions

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Bupivacaine 0,5%

Injection of bupivacaine 0,5% in group A

Intervention Type DRUG

Ropivacaine 0,75%

Injection of ropivacaine 0,75% in group B

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henrique Tedesco

OTHER

Sponsor Role lead

Responsible Party

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Henrique Tedesco

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Henrique T Oliveira

Role: CONTACT

55 51999601939

Facility Contacts

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Henrique T Oliveira

Role: primary

55 51999601939

References

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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.

Reference Type BACKGROUND
PMID: 34395901 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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89726325.2.0000.5327

Identifier Type: -

Identifier Source: org_study_id

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