Anesthesia, Local
Conditions
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.
Interventions
DRUGBupivacaine
1.5 ml of 0.55 bupivacaine solution to be used as postoperative anesthetic agent for prolonged analgesia
OTHERSALINE
1.5 ml of placebo (saline solution) to be injected into the opposite site postoperatively.
Sponsors
Cosmozone Dental Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS | 5 DAYS | THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH. | 5 DAYS | PATIENT WILL RECORD THE NUMBER OF ANALGESICS INGESTED IN A 5 DAY PERIOD AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS. |
| ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS | 5 DAYS | PATIENT WILL REGISTER ANY COMPLAINTS ARISING OUT OF ORAL ANALGESIC INTAKE |
| DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY | 1.5 TO 10 HOURS | PATIENTS WILL RECORD THE DURATION OF TISSUE ANESTHESIA AFTER THE SURGERY |
Outcome results
None listed