Comparison of the efficacy of ropivacaine on intraoperative and postoperative factors of an impacted third mandibular molar with lidocaine with epinephrine
Design
Controlled clinical trial with parallel groups, single-blind, randomized
Settings and conduct
Department of Oral and Maxillofacial Surgery, Mashhad Dental School. The patient, the outcome assessor, and the data analyst are unaware of the type of drug being injected in either direction.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA I or ASA II; informed consent; age between 18-30 years; two wisdom teeth (mesioangular impaction, level B, class 1 or 2) which are similar in terms of surgical severity; no general contraindications (low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, arousability, tachyphylaxis and liver disorders); No lesions and malignancies at the surgical site; No smoking. Exclusion criteria: wisdom tooth surgery on one side; occurring medical problems during surgery, need more than one cartridge injection, surgery lasting more than 20 minutes.
Intervention groups
Patients who require mandibular wisdom tooth surgery on both sides are included in the study and undergo split-mouth surgery under the anesthesia of ropivacaine and lidocaine. Lidocaine will be injected on one side and ropivacaine on the other.
Main outcome variables
Bleeding during surgery, the amount of pain during and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041425N3
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Majid Hosseini Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
hoseiniabrishamim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Rupivacain versus Lidocain effect on intraoperative bleeding and pain, and postoperative pain after wisdom tooth surgery
Public title
The comparison of Rupivacain versus Lidocain effect on intraoperative bleeding and pain, and postoperative pain after wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
According to the ASA physical status classification system, patient should be ASA I or ASA II (normal healthy patient or patient with mild systemic disease)
Patient with informed consent.
Patient's age should be between 18-30 years.
Patients should have two wisdom teeth (classified in the same class by Pell & Gregory; mesioangular impaction, level B, class 1 or 2), which are similar in terms of surgical severity
No general contraindications (patients with low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, arousability, tachyphylaxis and liver disorders.)
No lesions and malignancies at the surgical site; No smoking.
Exclusion criteria:
Patient with wisdom tooth surgery on one side Patient who needs more than one cartridge injection
Occurring medical problems during surgery;
Surgery lasting more than 20 minutes.
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Left and right mandibular impacted third molar
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization steps are as followed: for the first patient, two envelopes with the same appearance are selected, inside one of them there is a card on which dexmedetomidine in ropivacaine, and inside the other is a card on which lidocaine is written. After that, the surgeries are performed alternately. (Note that if for the first patient, surgery is performed by the ropivacaine; for the opposite tooth surgery, lidocaine will be used and vice versa.)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study blinded groups involves patients and persons who analyses the data. Participants will be unaware of the fact that they receive Rupvacaine or Lidocaine in which side ( of course during signing moral Satisfaction form ,they will be notified if they receive both of these two drugs.)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Science, Daneshgah Ave, Mashhad, Iran