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
About this trial
This is an interventional supportive care trial for Anesthesia, Local
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.
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
NCT ID
NCT02353676
First Posted
January 29, 2015
Last Updated
January 29, 2015
Sponsor
Cosmozone Dental Clinic
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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