Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction

NCT03950700 | Completed Phase 4 DMC

• 1 other identifier: 791
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The third molars are the teeth that are most frequently included and impacted, extraction is one of the most performed treatments by maxillofacial surgeons in their clinical practice. Its surgical extraction is accompanied by an inflammatory process, which generates pain, edema and trismus. The use of alternatives that offer prolonged analgesia, like the use of bupivacaine, reduce the pain of the patient after an extraction of third molars, allows the reduction of morbidity and the rapid return to daily activities. In addition, it allows a better experience in the dental consultation. Investigators hypothesis is: Irrigation of the alveolus with 4 ml of 0.5% bupivacaine is effective for the reduction of post-operative pain in extraction of impacted lower third molars

Conditions

Teeth, Impacted

Keywords

Analgesia; Bupivacaine; Postoperative pain; Third molar; Extraction

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measure: pain visual analog scale

  To identify the analgesia obtained with the alveolus irrigation with bupivacaine at 4, 12 and 24 postoperative hours, by applying the analogous visual pain scale in each third molar object of study. Postoperative pain will be evaluated at 4, 12 and 24 hours after surgery, using the Likert pain visual analog scale from 1 to 10. There being 1 absence of pain and 10 the worst pain imaginable.

  4, 12 and 24 postoperative hours

Study Arms (2)

Bupivacaine solution

EXPERIMENTAL

In all patients, both impacted lower third molars are surgically removed in one session, beginning the extractions in the right side. Subsequently, one of the alveolus will be irrigated with 4ml of bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000 (BUPIROP® 0.5% ROPSOHN THERAPEUTICS SAS), the contralateral alveolus will be irrigated with 4 ml of saline solution 0.9% (Baxter laboratories) prior to the placement of the suture for the closure of the surgical wound, using the aspiration to avoid the exit of the medication out of the alveolus.

Drug: Bupivacaine-epinephrine

Saline solution

PLACEBO COMPARATOR

In all patients, both impacted lower third molars are surgically removed in one session, beginning the extractions in the right side. Subsequently, one of the alveolus will be irrigated with 4ml of bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000 (BUPIROP® 0.5% ROPSOHN THERAPEUTICS SAS), the contralateral alveolus will be irrigated with 4 ml of saline solution 0.9% (Baxter laboratories) prior to the placement of the suture for the closure of the surgical wound, using the aspiration to avoid the exit of the medication out of the alveolus.

Drug: Saline Solution

Interventions

Bupivacaine-epinephrine DRUG

BUPIROP® 0.5% ROPSOHN THERAPEUTICS S.A.S

Also known as: Bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000

Bupivacaine solution

Saline Solution DRUG

Saline solution 0.9% (Baxter laboratories).

Also known as: Saline solution 0.9%

Saline solution

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lower third molars impacted bilaterally requiring an osteotomy for their extraction and which are located spatially within the following positions or classes according to Pell \& Gregory (1933).
• Position B (occlusal plane of the impacted tooth between the occlusal plane and the cervical line of the second molar).
• Position C (tooth impacted below the cervical line of the second molar).
• Class II (space between the second molar and the mandibular branch smaller than the distal mesial diameter of the third molar).
• Class III (All or most of the third molar is inside the mandibular branch).
• Systemically healthy patients (ASA I-II).

You may not qualify if:

• We exclude patients who present a history of infectious processes in the abscess area of third molars or who, for medical reasons, chronically use some type of analgesia.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

CES University

Medellín, Colombia

Location

Related Publications (2)

• Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prospects. 2010 Fall;4(4):105-9. doi: 10.5681/joddd.2010.027. Epub 2010 Dec 21.

  PMID: 23346335 RESULT

• Brajkovic D, Biocanin V, Milic M, Vucetic M, Petrovic R, Brkovic B. Quality of analgesia after lower third molar surgery: A randomised, double-blind study of levobupivacaine, bupivacaine and lidocaine with epinephrine. Vojnosanit Pregl. 2015 Jan;72(1):50-6. doi: 10.2298/vsp1501050b.

  PMID: 26043591 RESULT

MeSH Terms

Conditions

Tooth, Impacted; Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pablo Emilio Correa Echeverri

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The decision to use another substance for the irrigation of the alveolus will be taken in a randomized manner.Through numerical assignment according to the order of surgical scheduling. The patients with even numbers are irrigated on the right side with bupivacaine and on the left side with saline. Patients with odd numbers will be irrigated in the opposite way. Patients will be considered blinded to the drug of choice, and they will not know what type of solution will be administered on each side.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Posgraduates Programs of Dentistry

Model Details: In all patients, both impacted lower third molars are surgically removed in one session, beginning the extractions in the right side. Subsequently, one of the alveolus will be irrigated with 4ml of bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000 (BUPIROP® 0.5% ROPSOHN® THERAPEUTICS SAS), the contralateral alveolus will be irrigated with 4 ml of saline solution 0.9% (Baxter laboratories) prior to the placement of the suture for the closure of the surgical wound, using the aspiration to avoid the exit of the medication out of the alveolus.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)