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

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Other: SALINE; Drug: Bupivacaine

• Registration Number: NCT02353676
• Lead Sponsor: Cosmozone Dental Clinic

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.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-01-29
• Last Update Submitted: 2015-01-29
• Study First Posted: 2015-02-03
• Last Update Posted: 2015-02-03
• Primary Completion: 2015-06
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO GROUP	SALINE	1.5 ml of saline solution to be injected into the opposite site postoperatively.
BUPIVACAINE GROUP	Bupivacaine	1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively.

Primary Outcome Measures

Name	Time	Method
POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS	5 DAYS	THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.

Secondary Outcome Measures

Name	Time	Method
ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS	5 DAYS	PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE
NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.	5 DAYS	PATIENT WILL RECORD THE NUMBER OF ANALGESICS INGESTED IN A 5 DAY PERIOD AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.
DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY	1.5 TO 10 HOURS	PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY