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Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars

Primary Purpose

Anesthesia, Local

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine
SALINE
Sponsored by
Cosmozone Dental Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia, Local

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy ASA [American Society of Anaesthesiologists] class 1 patients with mandibular bilateral, symmetrical, impacted third molars indicated for extraction.

Exclusion Criteria:

  • unilateral impacted and bilateral asymmetrical impacted molars;
  • those who misused alcohol, had chronic pain,
  • those who took narcotic drugs, beta-blockers, or any analgesic drug within 24 hours before the operation
  • those with known hypersensitivity to amide types of local anesthetics.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BUPIVACAINE GROUP

    PLACEBO GROUP

    Arm Description

    1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively.

    1.5 ml of saline solution to be injected into the opposite site postoperatively.

    Outcomes

    Primary Outcome Measures

    POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS
    THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.

    Secondary Outcome Measures

    NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.
    PATIENT WILL RECORD THE NUMBER OF ANALGESICS INGESTED IN A 5 DAY PERIOD AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.
    ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS
    PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE
    DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY
    PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY

    Full Information

    First Posted
    January 29, 2015
    Last Updated
    January 29, 2015
    Sponsor
    Cosmozone Dental Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02353676
    Brief Title
    Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars
    Official Title
    Bupivacaine For Postoperative Pain Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    July 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cosmozone Dental Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.
    Detailed Description
    The study intends to enroll 100 patients [ASA 1] with bilateral symmetrical impacted mandibular third molars requiring surgical removal under local anesthesia. 2% Lidocaine hydrochloride with epinephrine bitartrate 1: 80000 in 3ml quantity will be utilized to achieve local anesthesia at the surgical site on both quadrants. Additional supplementation postoperative at the surgical site will be provided with either 1.5 ml of 0.5% bupivacaine with 1:80000 epinephrine solution or saline based on a split mouth randomized study design using a color and number coded envelop. All procedures will be performed by a single surgeon using a similar technique, under identical conditions at one month apart intervals. Pain scores will be assessed by the patient based on a 10cm Visual Analog Scale at intervals of 2, 4, 6, 12, 24, 36, 48, 72, 96 and 120 hours. The duration of soft tissue anesthesia postoperatively will be recorded by the patient. The number of analgesics ingested over 120 hours will be recorded by the patient. Results will be evaluated statistically by the Wilcoxon test and two tailed test to determine the ratio. Statistical significance will be considered at p < 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Local

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BUPIVACAINE GROUP
    Arm Type
    Experimental
    Arm Description
    1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively.
    Arm Title
    PLACEBO GROUP
    Arm Type
    Placebo Comparator
    Arm Description
    1.5 ml of saline solution to be injected into the opposite site postoperatively.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    ANAWIN
    Intervention Description
    1.5 ml of 0.55 bupivacaine solution to be used as postoperative anesthetic agent for prolonged analgesia
    Intervention Type
    Other
    Intervention Name(s)
    SALINE
    Intervention Description
    1.5 ml of placebo (saline solution) to be injected into the opposite site postoperatively.
    Primary Outcome Measure Information:
    Title
    POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS
    Description
    THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.
    Time Frame
    5 DAYS
    Secondary Outcome Measure Information:
    Title
    NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.
    Description
    PATIENT WILL RECORD THE NUMBER OF ANALGESICS INGESTED IN A 5 DAY PERIOD AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.
    Time Frame
    5 DAYS
    Title
    ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS
    Description
    PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE
    Time Frame
    5 DAYS
    Title
    DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY
    Description
    PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY
    Time Frame
    1.5 TO 10 HOURS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy ASA [American Society of Anaesthesiologists] class 1 patients with mandibular bilateral, symmetrical, impacted third molars indicated for extraction. Exclusion Criteria: unilateral impacted and bilateral asymmetrical impacted molars; those who misused alcohol, had chronic pain, those who took narcotic drugs, beta-blockers, or any analgesic drug within 24 hours before the operation those with known hypersensitivity to amide types of local anesthetics.

    12. IPD Sharing Statement

    Learn more about this trial

    Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars

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