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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bupivacaine For Postoperative Pain Control

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Bupivacaine
* Other: SALINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUPIVACAINE GROUP<br>1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively. | Drug: Bupivacaine<br>* 1.5 ml of 0.55 bupivacaine solution to be used as postoperative anesthetic agent for prolonged analgesia<br>* Other names: ANAWIN;|
| Placebo Comparator: PLACEBO GROUP<br>1.5 ml of saline solution to be injected into the opposite site postoperatively. | Other: SALINE<br>* 1.5 ml of placebo (saline solution) to be injected into the opposite site postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS | THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS. | 5 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 DAYS | 
| ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS | PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE | 5 DAYS | 
| DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY | PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY | 1.5 TO 10 HOURS |