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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

Page last updated: August 23, 2015

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