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

Anesthesia, Local Clinical Trial

Official title:

Bupivacaine For Postoperative Pain Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02353676
• Other study ID #: COSMOZONE
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2015
• Last updated: January 29, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Cosmozone Dental Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
1.5 ml of 0.55 bupivacaine solution to be used as postoperative anesthetic agent for prolonged analgesia

Other:
• SALINE
1.5 ml of placebo (saline solution) to be injected into the opposite site postoperatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cosmozone Dental Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS	THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.	5 DAYS	No
Secondary	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	No
Secondary	ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS	PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE	5 DAYS	Yes
Secondary	DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY	PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY	1.5 TO 10 HOURS	No