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

Bupivacaine For Postoperative Pain Control

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Bupivacaine; Other: SALINE

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cosmozone Dental Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: January 29, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: COSMOZONE