Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars
Information source: Cosmozone Dental Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, Local
Intervention: Bupivacaine (Drug); SALINE (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Cosmozone Dental Clinic
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.
Clinical Details
Official title: Bupivacaine For Postoperative Pain Control
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Primary outcome: POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS
Secondary outcome: NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: January 2015
Last updated: January 29, 2015
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