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

NCT ID: NCT02353676

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BUPIVACAINE GROUP

1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

PLACEBO GROUP

1.5 ml of saline solution to be injected into the opposite site postoperatively.

Group Type: PLACEBO_COMPARATOR

SALINE

Intervention Type: OTHER

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

SALINE

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

Intervention Type: OTHER

Other Intervention Names

ANAWIN

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosmozone Dental Clinic

OTHER

Sponsor Role: lead

Responsible Party

pavan MANOHAR PATIL

DIRECTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

COSMOZONE

Identifier Type: -

Identifier Source: org_study_id