Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction
Condition: Teeth, Impacted
MeSH terms: Tooth, Impacted; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Clinical, randomized, experimental, single blind study. The sample for the present study will
      consist of 40 patients who attend consecutively to maxillofacial surgery, to perform third
      molar surgical extraction.

      The sample size defined for the present study is 40 patients, each with two extractions of
      third molars for a total of 80 extractions that will be randomized in each patient for the
      treatment of Bupivacaine and saline respectively.

      For the calculation of statistical power with the sample size previously defined to compare
      the postoperative pain level 4, 12 and 24 hours after the extraction of lower third molars in
      two groups (Bupivacaine and saline).

      With the sample size, investigators defined, calculated, statistical power, test and use,
      comparison, pain levels, at 4 and 12 hours, with a power greater than 90%. The study will
      have sufficient power for the study to be conclusive, regardless of whether it finds
      statistically significant differences or not.

      The surgical procedure will be performed by a single oral and maxillofacial surgeon,
      following the same surgical technique for the extraction of impacted molars, in all patients,
      including the sulcular flap up to the second molar, with a posterior complementary incision
      of 45 degrees, without anterior incision Complementary. The osteotomy is performed with a
      high speed carbide surgical bur. The patients will not receive a previous medication.

      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%), 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.

      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.

      Before starting the surgical procedure, the disposable syringes will be marked with their
      respective content, either bupivacaine 0.5% or saline solution 0.9%, each with 4 ml of the
      medication.

      Patients will be considered blinded to the drug of choice, and patients will not know what
      type of solution will be administered on each side.

      All patients will be medicated with: amoxicillin 500mg every 6 hours for 7 days,
      acetaminophen 500mg every 6 hours for 5 days, and ibuprofen 400mg every 6 hours for 5 days.

      Postoperative pain will be evaluated at 4, 12 and 24 hours after surgery, using the pain
      visual analog scale from 1 to 10, by telephone call. Patients will be instructed to rate
      their pain intensity on each side from one to ten.

      The information collected in the form will be digitized in a spreadsheet in Excel, to be
      analyzed in the program IBM® SPSS® version 21. All independent quantitative variables will be
      summarized by descriptive statistics (average or median, standard deviation o Interquartile
      range), while qualitative variables will be described with proportions. To compare the pain
      levels between the two treatments at 4, 12 and 24 hours, the Student's t-test for independent
      samples or, failing that, the Mann-Whitney U-test will be used.

      Prior to this analysis, the normality of the postoperative pain variable (analogous visual
      scale) will be assessed using the Shapiro Wilk test. A level of significance of 5% will
      always be assumed for the contrasting statistical tests.

      The univariate descriptive analysis will be presented through a summary table. In addition,
      an error bar graph will be used to show the levels of postoperative pain for each treatment
      at 4, 12 and 24 hours.

      The clinical trial embraces the Declaration of Helsinki of ethical principles for medical
      research in humans.

      Prior to carrying out the study, each of the participants will be explained what the research
      consists of, participants will be informed about possible adverse reactions to the local
      anesthetic Bupivacaine, such as drug reaction, altered blood pressure and heart rate, nausea.
      , vomiting, headaches and allergic skin reactions. At all times there will be a diligent
      management of the therapy and close observation establish the rules for the handling of
      personal data in clinical history.

      An informed consent will be given to each patient, who will read and explain what is
      stipulated in it before consenting, to ensure that the participant who signs the informed
      consent agrees to perform the procedure as stipulated in the statement of the investigation.

      The privacy of the individual, subject of investigation, will be protected, identifying it
      only when the results require it and this authorizes it.

      The investigation will be suspended immediately, upon noticing any risk or damage to the
      health of the subject in whom the investigation is carried out.
    

Intervention name(s): Bupivacaine-epinephrine; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): BUPIROP® 0.5% ROPSOHN THERAPEUTICS S.A.S; Saline solution 0.9% (Baxter laboratories).
Other intervention name(s): Bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000; Saline solution 0.9%
Intervention MeSH terms: Epinephrine; Vasoconstrictor Agents; Bupivacaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Analgesia; Bupivacaine; Postoperative pain; Third molar; Extraction