Comparision between of Ropivacaine and Lidocain with Epinephrin in patient undergoing cleft palate repair
Design
Clinical trial without control group, with parallel groups, one-way blind, randomized, phase 2 on 40 patients. Random allocation was used for randomization.
Settings and conduct
Intervention group 1: Lidocaine 2 mg per kg body weight with epinephrine 1/80000, Intervention group 2: ropevacaine 2 mg per kg body weight of solution o.5% is injected locally at the incision site by the surgical service.This single-blind study, which is used in patients before surgery, patients do not know the type of drug used
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for cleft palate surgery
Exclusion criteria: Allergy to local anesthetics; Bleeding disorders; Cardiovascolar disorders; Brain disorders
Intervention groups
Intervention group 1: Lidocaine 2 mg per kg body weight with epinephrine 1/80000 Intervention group 2: ropevacaine 2 mg per kg body weight solution 0.5% is injected locally at the incision site by the surgical service.
Main outcome variables
Complications of anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210515051299N1
Registration date:2021-05-24, 1400/03/03
Registration timing:prospective
Last update:2021-05-24, 1400/03/03
Update count:0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
sheida shabanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
shabanian23@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision between of Ropivacaine and Lidocain with Epinephrin in patient undergoing cleft palate repair
Public title
Comparision between of Ropivacaine and Lidocain with Epinephrin in patient undergoing cleft palate repair
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for cleft palate surgery
Exclusion criteria:
Allergy to local anesthetics,and bleeding disorders
Bleeding disorders
Cardiovascolar disorders
Brain disorders
Age
From 6 months old to 2 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization list will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained
Blinding (investigator's opinion)
Single blinded
Blinding description
Relevant drugs will be prepared and coded by the pharmacist (research project consultant) and the researcher will be unaware of the type of drug prescribed to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
This study was designed as a single-blinded randomized clinical trial with parallel groups and a sample size of 20 people in each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.055
Health conditions studied
1
Description of health condition studied
Cleft palate
ICD-10 code
Q35
ICD-10 code description
Cleft palate
Primary outcomes
1
Description
Complications of anesthesia, including heart rate, blood pressure and anesthesia.
Timepoint
During anesthesia
Method of measurement
check of vital sign
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: lidocaine 2 mg per kilogram of body weight with epinephrine 1/80000 is injected locally at the incision site by the surgical service.
Category
Prevention
2
Description
Intervention group2:ropevacaine Lidocaine 2 mg per kilogram of body weight solution 0.5% is injected locally at the incision site by the surgical service