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

NCT02353676 | Unknown

• 1 other identifier: COSMOZONE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS

  THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.

  5 DAYS

Secondary Outcomes (3)

• NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.

  5 DAYS

• ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS

  5 DAYS

• DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY

  1.5 TO 10 HOURS

Study Arms (2)

BUPIVACAINE GROUP

EXPERIMENTAL

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

Drug: Bupivacaine

PLACEBO GROUP

PLACEBO COMPARATOR

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

Other: SALINE

Interventions

Bupivacaine DRUG

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

Also known as: ANAWIN

BUPIVACAINE GROUP

SALINE OTHER

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

PLACEBO GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy ASA \[American Society of Anaesthesiologists\] class 1 patients with mandibular bilateral, symmetrical, impacted third molars indicated for extraction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmozone Dental Clinic: lead

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-01