Evaluation of using Ropivacaine as a long acting anesthesia on systemic factors, amount of using opioid and bleeding during operation and post-operative pain in orthognathic surgery comparing with lidocaine
The purpose of this study is to evaluate effect of using Ropivacaine on systemic factors, use of opioids and bleeding during orthognathic surgery and post operative pain control comparing with use of Lidocaine.
Design
Two arm parallel group randomised trial with double blinding
Settings and conduct
The patients with cl III skeletal deformity up to 10 milimeters will be bedded at maxillofacial surgery service at Ghaem hospital of Mashhad.Patients are divided to two 20 groups.At first group 2cc Ropivacaine 0/5% at BSSO incision site and 4cc at Lefort incision site will be used.At the second group 1/8cc Lidocaine 2% with Epinephrine 1/100000 at BSSO incision site and 3/6cc at Lefort incision site will be used.Then during operation amounts of using opiods, amounts of bleeding with suctioned bloods, systemic factors including heart rate, mean arterial pressure, breathing, SPo2 with monitoring device will be messured at esch group and will compare with each other.Also amounts of pain after operation at each group will be messured at 2, 6, 12, 18, 24 hours after operation via VAS scale and compared with each other.This study is double blinded and blinding is done for patients under study and analysts.
Participants/Inclusion and exclusion criteria
patients with cl III deformity up to 10 milimeters is the condition of enterance to study and presence of systemic disease especially kidney disease is the condition of not entering to study.
Intervention groups
The intervention group at this study consists of patients candidate for orthognathic surgery that Ropivacaine is used as preoperative local anesthesia.
Main outcome variables
Amounts of using opoids during operation; Amounts of bleeding; Amounts of systemic factors including mean arterial pressure, breathing, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170718035163N1
Registration date:2019-07-20, 1398/04/29
Registration timing:registered_while_recruiting
Last update:2019-07-20, 1398/04/29
Update count:0
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
Mozhgan Kazemian
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9512
Email address
kazemianmz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of using Ropivacaine as a long acting anesthesia on systemic factors, amount of using opioid and bleeding during operation and post-operative pain in orthognathic surgery comparing with lidocaine
Public title
Evaluation of using Ropivacaine in orthognathic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who have cl III with discrepancy up to 10 mm.
Exclusion criteria:
The patients who have systemic diseases especially kidney disease.
The patients who have history of allergy to drugs using in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method of this study is blocked.This method is used to prevent significant imbalances in the number of participants assigned to each group.
This randomization guarantees that during periods of randomization, no significant imbalance exists between groups
For this method, the size of each block must first be determined and Then write the list of blocks and assign them numbers.The randomization unit is individual.The randomization tool is Statistical software .
Blinding (investigator's opinion)
Double 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 ( of course during signing moral Satisfaction form ,they will be notified if they receive one of these two drugs.)
Data will be grouped into groups A and B for delivery to the statistician.
The statistician is unaware of which group of drugs he received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of mashhad university of medical Sciences
Systemic factors including heart rate, mean arterial pressure, breathing, SPo2
Timepoint
Evaluating systemic factors 15, 30, 45, 60, 75, 90, 105, 120 minutes after starting the surgery.
Method of measurement
Monitoring device
Secondary outcomes
1
Description
Evaluating the amounts of pain after surgery
Timepoint
Evaluating pain 2, 6, 12, 18, 24 hours after surgery
Method of measurement
VAS scale
2
Description
Amounts of using narcotics during surgery
Timepoint
Measuring narcotic consumption after starting surgery
Method of measurement
Determined by anesthetic team.
Intervention groups
1
Description
Intervention group: includes group that 2cc Ropivacaine 0/5% (naropin) as preoperative anesthesia at BSSO incision and 4cc at lefort incision before begining orthognathic surgery are used.
Category
Treatment - Surgery
2
Description
Control group: includes group that 1/8cc Lidocaine 2% with epinephrine 1/80000 (Persocaine) as preoperative anesthesia at BSSO incision and 3/6cc at lefort incision before begining orthognathic surgery are used.